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

Teva Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Losartan potassium/Hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01149473

B046515

Details and patient eligibility

About

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.

Full description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.