Trials / Completed
CompletedNCT00841815
Amlodipine 10 mg Tablets Under Fed Conditions
A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 fed conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amlodipine Besylate | 10 mg Tablet |
| DRUG | Norvasc® | 10 mg Tablet |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2003-05-01
- Completion
- 2003-05-01
- First posted
- 2009-02-11
- Last updated
- 2024-08-20
- Results posted
- 2009-08-18
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00841815. Inclusion in this directory is not an endorsement.