drugset / Trial / NCT00649597

Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg

NCT00649597

Phase 1 Completed 56 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.

Timeline

Start
2002-11
Primary completion
2002-12
Completion
2002-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Benazepril Unknown 40 mg Oral
Subject Hydrochlorothiazide Unknown 50 mg Oral

Indications

No indication recorded.