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Trial record 91 of 766 for:    Area Under Curve AND Bioavailability

Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

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: NCT01177293
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Sponsor:
Collaborators:
Aurobindo Pharma Ltd
Trident Life Sciences Ltd.
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Amlodipine - reference
Drug: Amlodipine ODT - test
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amlodipine Capsule Then Amlodipine ODT Amlodipine ODT Then Amlodipine Capsule
Hide Arm/Group Description Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period. Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
Period Title: First Intervention Period
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Washout Period (of 14 Days)
Started 7 7
Completed 7 6
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Second Intervention Period
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
25.00  (6.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
0
   0.0%
Male
14
 100.0%
1.Primary 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, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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.
Arm/Group Title Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Hide Arm/Group Description:
Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
Overall Number of Participants Analyzed 12 13
Geometric Mean (Full Range)
Unit of Measure: hr*ng/mL
401.655
(61.74 to 566.54)
360.619
(266.76 to 635.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg Capsule, Amlodipine 10 mg ODT
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUC[0- ∞] of amlodipine 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.
Method of Estimation Estimation Parameter Adjusted geometric means ratio
Estimated Value 89.78
Confidence Interval (2-Sided) 90%
82.74 to 97.43
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 time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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 Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Hide Arm/Group Description:
Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
Overall Number of Participants Analyzed 12 13
Geometric Mean (Full Range)
Unit of Measure: hr*ng/mL
331.300
(60.42 to 463.69)
330.394
(243.87 to 558.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg Capsule, Amlodipine 10 mg ODT
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed AUClast of amlodipine 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.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio
Estimated Value 99.73
Confidence Interval (2-Sided) 90%
85.10 to 116.87
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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 Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Hide Arm/Group Description:
Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
Overall Number of Participants Analyzed 12 13
Geometric Mean (Full Range)
Unit of Measure: ng/mL
6.427
(1.88 to 8.32)
5.571
(3.92 to 7.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amlodipine 10 mg Capsule, Amlodipine 10 mg ODT
Comments A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Natural log transformed Cmax of amlodipine 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.
Method of Estimation Estimation Parameter Adjusted geometric means ratio
Estimated Value 86.67
Confidence Interval (2-Sided) 90%
79.57 to 94.42
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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 Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Hide Arm/Group Description:
Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
Overall Number of Participants Analyzed 12 13
Median (Full Range)
Unit of Measure: hr
8.00
(6.00 to 14.00)
10.00
(6.00 to 14.00)
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, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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 Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Hide Arm/Group Description:
Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: hr
51.374  (12.912) 45.120  (4.921)
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 Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Hide Arm/Group Description Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]). Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
All-Cause Mortality
Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amlodipine 10 mg Capsule Amlodipine 10 mg ODT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01177293    
Other Study ID Numbers: A0531096
052-10
First Submitted: March 10, 2010
First Posted: August 6, 2010
Results First Submitted: June 28, 2011
Results First Posted: August 30, 2011
Last Update Posted: August 30, 2011