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 rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Losartan 100mg Tablets arm 2: Cozaar® 100 mg Tablets

Interventions: intervention 1: Losartan intervention 2: Cozaar®
Intervention descriptions: intervention 1: 100 mg Tablet intervention 2: 100 mg Tablet

Protocol document: