NCT01124175

Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions

Randomized, 2-way Crossover, Bioequivalence Study of Losartan 100 mg Tablets and Cozaar® Administered as 1 * 100 mg Tablet in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Losartan	100 mg Tablets
DRUG	Cozaar®	100 mg Tablets

Timeline

• Start date: 2003-10-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2010-05-14
• Last updated: 2024-08-19
• Results posted: 2010-07-19

Locations

1 site across 1 country: Canada