Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under 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: Hyzaar®
Intervention descriptions: intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets

Protocol document: