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Trial record 31 of 1423 for:    Area Under Curve AND tablet

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

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ClinicalTrials.gov Identifier: NCT01254396
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : February 8, 2012
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Erectile Dysfunction
Intervention Drug: Sildenafil
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sildenafil Fasted First, Then Sildenafil Fed Sildenafil Fed First, Then Sildenafil Fasted
Hide Arm/Group Description Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period. Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
Period Title: First Intervention Period
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Washout Period (at Least 1 Day)
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Second Intervention Period
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
56.6  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
0
   0.0%
Male
12
 100.0%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
Arm/Group Title Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Hide Arm/Group Description:
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
292.60  (93.84) 121.00  (56.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sildenafil 50 mg (Fasted), Sildenafil 50 mg (Fed)
Comments Natural log transformed Cmax of sildenafil 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 for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 41.35
Confidence Interval (2-Sided) 90%
32.40 to 52.76
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
Arm/Group Title Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Hide Arm/Group Description:
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
813.20  (186.29) 712.80  (245.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sildenafil 50 mg (Fasted), Sildenafil 50 mg (Fed)
Comments Natural log transformed AUClast of sildenafil 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 for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 87.66
Confidence Interval (2-Sided) 90%
77.62 to 98.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
Arm/Group Title Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Hide Arm/Group Description:
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: hrs
0.625
(0.250 to 1.500)
4.000
(0.500 to 6.000)
4.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Hide Description AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Hide Arm/Group Description:
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
838.60  (197.20) 804.00  (284.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sildenafil 50 mg (Fasted), Sildenafil 50 mg (Fed)
Comments Natural log transformed AUC (0-∞) of sildenafil 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 for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 93.42
Confidence Interval (2-Sided) 90%
80.23 to 108.78
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Plasma Decay Half Life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Arm/Group Title Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Hide Arm/Group Description:
Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: hrs
3.039  (0.484) 2.503  (0.359)
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 Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Hide Arm/Group Description Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period. Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
All-Cause Mortality
Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sildenafil 50 mg (Fasted) Sildenafil 50 mg (Fed)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/12 (25.00%)   3/12 (25.00%) 
General disorders     
Catheter site haematoma * 1  2/12 (16.67%)  0/12 (0.00%) 
Nervous system disorders     
Headache * 1  0/12 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Dry throat * 1  1/12 (8.33%)  1/12 (8.33%) 
Nasal congestion * 1  1/12 (8.33%)  2/12 (16.67%) 
Skin and subcutaneous tissue disorders     
Dry skin * 1  1/12 (8.33%)  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
AUC (0-t) was the intended primary outcome measure.
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: NCT01254396     History of Changes
Other Study ID Numbers: A1481290
First Submitted: November 19, 2010
First Posted: December 6, 2010
Results First Submitted: January 7, 2012
Results First Posted: February 8, 2012
Last Update Posted: February 8, 2012