NCT01149473

Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions

A Relative Bioavailability Study of Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets Under Non-Fasting 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 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Losartan potassium/Hydrochlorothiazide	100/25 mg Tablets
DRUG	Losartan potassium/Hydrochlorothiazide	100/25 mg Tablets

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2010-06-23
• Last updated: 2024-08-20
• Results posted: 2010-09-14

Locations

1 site across 1 country: United States