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An Open-label Randomized, Single Dose, Two Way Crossover Oral Bioequivalence Study of Amlodipine Besylate/Benazepril HCl Capsules of Dr. Reddy's With Lotrel® Capsules of Novartis in Human Subjects Under Fed Conditions
The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.
Details
| Lead sponsor | Dr. Reddy's Laboratories Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 49 |
| Start date | 2007-03 |
| Completion | 2007-05 |
Conditions
- Fed
Interventions
- Amlodipine Besylate/Benazepril HCl
Primary outcomes
- Bioequivalence is based on Cmax and AUC parameters — 3 months
Countries
India