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

NCT ID: NCT01149473

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2004-04-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Generic Test Product

Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets

Group Type: EXPERIMENTAL

Losartan potassium/Hydrochlorothiazide

Intervention Type: DRUG

100/25 mg Tablets

Reference Listed Drug

Hyzaar® 100/25 mg Tablets

Group Type: ACTIVE_COMPARATOR

Losartan potassium/Hydrochlorothiazide

Intervention Type: DRUG

100/25 mg Tablets

Interventions

Losartan potassium/Hydrochlorothiazide

100/25 mg Tablets

Intervention Type: DRUG

Losartan potassium/Hydrochlorothiazide

100/25 mg Tablets

Intervention Type: DRUG

Other Intervention Names

Hyzaar®

Eligibility Criteria

Inclusion Criteria

• Healthy, non-smoking, male and female subjects at least 18 years of age.
• BMI (body mass index) of 30 or less.
• Females in this study must be physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile).
• Successful completion of a physical examination within 28 days of initiation of the study.
• Negative serum pregnancy test (females).

Exclusion Criteria

• Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis, or glaucoma will not be eligible for this study.
• Subjects whose clinical laboratory test values are outside the reference range and are deemed clinically significant by the Principle Investigator.
• Subjects who have a history of allergic responses to the classes of drugs being tested will be excluded from the study.
• Subjects who use tobacco in any form will not be eligible to participate in the study. 3 months abstinence is required.
• Subjects found to have urine concentrations of any of the tested drugs of abuse will not be allowed to participate.
• Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
• Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
• Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
• All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
• Subjects who do not tolerate venipuncture will not be allowed to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Pharmaceuticals USA

Principal Investigators

James D Carlson, Pharm D

Role: PRINCIPAL_INVESTIGATOR

PRACS Institute, Ltd.

Locations

PRACS Institute, Ltd.

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

B046515

Identifier Type: -

Identifier Source: org_study_id