Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 80
Healthy volunteers: yes

Brief summary:
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets

Interventions: intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Losartan potassium/Hydrochlorothiazide
Intervention descriptions: intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets

Protocol document: