Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions
Summary
The objective of this study is to compare the rate and extent of absorption if amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as 1 x 10 mg- 20 mg capsule under fed conditions.
Timeline
- Start
- 2004-03
- Primary completion
- 2004-03
- Completion
- 2004-03
Outcome
Met primary endpoint
registry description: Bioequivalence based on Cmax - Maximum observed concentration NCT00835367 ↗
registry Ratio of Least Squares Means 101.84 (90% CI 98.22 to 105.59) NCT00835367 ↗
registry Ratio of Least Squares Means 102.49 (90% CI 99.75 to 105.30) NCT00835367 ↗
registry Ratio of Least Squares Means 91.79 (90% CI 84.83 to 99.32) NCT00835367 ↗
registry Ratio of Least Squares Means 102.74 (90% CI 100.35 to 105.19) NCT00835367 ↗
registry Ratio of Least Squares Means 102.72 (90% CI 100.30 to 105.20) NCT00835367 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 10 mg | — |
| Subject | Benazepril | Unknown | 20 mg | — |
| Comparator | Lotrel | Unknown | — | — |
Indications
No indication recorded.