drugset / Trial / NCT00649519

Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg

NCT00649519

Phase 1 Completed 54 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.

Timeline

Start
2004-05
Primary completion
2004-05
Completion
2004-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 10 mg Oral
Subject Benazepril Unknown 20 mg Oral

Indications

No indication recorded.