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

Condition(s) targeted: Healthy

Intervention: Losartan potassium/Hydrochlorothiazide (Drug); Losartan potassium/Hydrochlorothiazide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
James D Carlson, Pharm D, Principal Investigator, Affiliation: PRACS Institute, Ltd.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)

AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)

Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)

AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

PRACS Institute, Ltd., Fargo, North Dakota 58104, United States

Starting date: March 2004
Last updated: August 16, 2010