Amlodipine 10 mg Tablets Under Fasting Conditions
- Registration Number
- NCT00841542
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fasting conditions.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Norvasc® Norvasc® Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period Amlodipine Besylate Amlodipine Besylate Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
- Primary Outcome Measures
Name Time Method Cmax - Maximum Observed Concentration Blood samples collected over 168 hour period Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) Blood samples collected over 168 hour period Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) Blood samples collected over 168 hour period Bioequivalence based on AUC0-t
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Biovail Contract Research
🇨🇦Toronto, Ontario, Canada