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Trial record 80 of 730 for:    Area Under Curve AND Bioavailability

This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01286454
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : January 9, 2012
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
Intervention Drug: fesoterodine
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER Fesoterodine 4 mg 10% ER Fed
Hide Arm/Group Description Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
Period Title: Part I- First Intervention Period
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period (At Least 3 Days)
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Second Intervention Period
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period (At Least 3 Days)
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Third Intervention Period
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period (At Least 3 Days)
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Fourth Intervention Period
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period (At Least 3 Days)
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Fifth Intervention Period
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period (Approximately 2 Weeks)
Started 2 2 2 2 2 2 2 2 2 2 0
Completed 2 2 2 2 2 2 2 2 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Part II- Sixth Intervention Period
Started 0 0 0 0 0 0 0 0 0 0 20
Completed 0 0 0 0 0 0 0 0 0 0 20
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
39.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
1.Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Hide Description AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.
Arm/Group Title Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Hide Arm/Group Description:
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Overall Number of Participants Analyzed 20 20 16 4 20 20
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
30.48  (11.77) 28.24  (10.35) 19.64  (7.58) NA [1]   (NA) 27.40  (10.06) 32.07  (13.24)
[1]
Parameter was missing for more than 50 percent of the participants.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg IR-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 111.23
Confidence Interval (2-Sided) 90%
102.69 to 120.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 103.07
Confidence Interval (2-Sided) 90%
95.16 to 111.64
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 15% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 70.36
Confidence Interval (2-Sided) 90%
64.52 to 76.74
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg 10% ER-BIC Fed
Comments Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 113.55
Confidence Interval (2-Sided) 90%
105.91 to 121.74
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Hide Arm/Group Description:
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Overall Number of Participants Analyzed 20 20 20 20 20 20
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
30.23  (11.79) 27.79  (10.21) 17.92  (6.95) 7.59  (3.57) 26.80  (10.07) 31.88  (13.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg IR-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 112.80
Confidence Interval (2-Sided) 90%
103.85 to 122.52
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 103.71
Confidence Interval (2-Sided) 90%
95.48 to 112.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 15% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 66.87
Confidence Interval (2-Sided) 90%
61.56 to 72.63
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 20% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 28.34
Confidence Interval (2-Sided) 90%
26.09 to 30.78
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg 10% ER-BIC Fed
Comments Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 114.70
Confidence Interval (2-Sided) 90%
106.99 to 122.97
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Hide Arm/Group Description:
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Overall Number of Participants Analyzed 20 20 20 20 20 20
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
5.830  (2.729) 3.030  (1.068) 1.092  (0.496) 0.323  (0.183) 2.247  (1.000) 5.183  (1.919)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg IR-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 259.40
Confidence Interval (2-Sided) 90%
231.48 to 290.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 134.83
Confidence Interval (2-Sided) 90%
120.31 to 151.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 15% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 48.58
Confidence Interval (2-Sided) 90%
43.35 to 54.44
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 20% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
Comments Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 14.38
Confidence Interval (2-Sided) 90%
12.83 to 16.11
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg 10% ER-BIC Fed
Comments Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 171.06
Confidence Interval (2-Sided) 90%
115.82 to 187.78
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Hide Arm/Group Description:
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Overall Number of Participants Analyzed 20 20 20 20 20 20
Median (Full Range)
Unit of Measure: hr
1.0
(0.5 to 5.0)
6.0
(5.0 to 8.0)
6.0
(5.0 to 10.0)
8.0
(5.0 to 24.0)
5.0
(2.0 to 6.0)
4.0
(3.0 to 6.0)
5.Secondary Outcome
Title Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.
Arm/Group Title Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Hide Arm/Group Description:
Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Overall Number of Participants Analyzed 20 20 16 4 20 20
Mean (Standard Deviation)
Unit of Measure: hr
5.56  (1.70) 7.22  (1.68) 10.89  (4.45) NA [1]   (NA) 7.54  (2.49) 4.59  (0.76)
[1]
Parameter was missing for more than 50 percent of the participants.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Hide Arm/Group Description Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods. Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods. Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
All-Cause Mortality
Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fesoterodine 4 mg IR-BIC Fasted Fesoterodine 4 mg 10% ER-BIC Fasted Fesoterodine 4 mg 15% ER-BIC Fasted Fesoterodine 4 mg 20% ER-BIC Fasted Fesoterodine 4 mg ER Tablet Fasted Fesoterodine 4 mg 10% ER-BIC Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/20 (35.00%)   4/20 (20.00%)   6/20 (30.00%)   0/20 (0.00%)   4/20 (20.00%)   6/20 (30.00%) 
Gastrointestinal disorders             
Diarrhoea * 1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Dry mouth * 1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nausea * 1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
General disorders             
Feeling cold * 1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vessel puncture site haematoma * 1  1/20 (5.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Vessel puncture site pain * 1  1/20 (5.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%) 
Infections and infestations             
Viral infection * 1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Viral upper respiratory tract infection * 1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders             
Back pain * 1  2/20 (10.00%)  1/20 (5.00%)  3/20 (15.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nervous system disorders             
Headache * 1  1/20 (5.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%) 
Psychiatric disorders             
Insomnia * 1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal pain * 1  1/20 (5.00%)  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  1/20 (5.00%)  3/20 (15.00%) 
Skin and subcutaneous tissue disorders             
Pruritis * 1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01286454     History of Changes
Other Study ID Numbers: A0221068
First Submitted: December 3, 2010
First Posted: January 31, 2011
Results First Submitted: December 1, 2011
Results First Posted: January 9, 2012
Last Update Posted: January 26, 2012