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

NCT ID: NCT01149486

Last Updated: 2010-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2004-02-29

Brief Summary

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck & Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• 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

Hyzaar®

Intervention Type: DRUG

100/25 mg Tablets

Interventions

Losartan potassium/Hydrochlorothiazide

100/25 mg Tablets

Intervention Type: DRUG

Hyzaar®

100/25 mg Tablets

Intervention Type: DRUG

Other Intervention Names

Losartan potassium/Hydrochlorothiazide (generic name)

Eligibility Criteria

Inclusion Criteria

• Healthy men and women, 18-45 years of age (inclusive).
• Body mass index should be less than or equal to 30
• Screening procedures completed within 28 days prior to dosing.
• If female and:

• of child bearing potential, is practicing an acceptable barrier method of birth control for the duration of the study
• is postmenopausal for at least 1 year
• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria

• Subjects with a recent history of drug or alcohol abuse or addiction.
• Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
• Subjects whose clinical laboratory test values the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
• Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
• Subjects demonstrating a positive drug abuse screen when screened for the study.
• Female subjects demonstrating a positive pregnancy screen.
• Female subjects who are currently breastfeeding.
• Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or hormonal contraceptives within 14 days of dosing will not be allowed to participate.
• Subjects with a history of allergic response(s) to losartan, hydrochlorothiazide or related drugs.
• Subjects with a history of clinically significant allergies including drug allergies.
• Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).
• Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to dosing.
• Subjects who have used tobacco products within 90 days of Period 1 dose administration.
• Subjects who report donating greater than 150 mL of blood within 14 days prior to dosing.
• Subjects who report receiving any investigational drug within 28 days prior to dosing.
• Subjects who report taking any systemic prescription medication in the 14 days prior to dosing.
• Subjects who report an intolerance of direct venipuncture.
• Subjects who report consuming an abnormal diet within the 28 days prior to dosing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

R04-080

Identifier Type: -

Identifier Source: org_study_id