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

Overview

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 Title of Study: “A Relative Bioavailability Study of Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets Under Non-Fasting Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2004

Detailed Description

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

Interventions

  • Drug: Losartan potassium/Hydrochlorothiazide
    • 100/25 mg Tablets
  • Drug: Losartan potassium/Hydrochlorothiazide
    • 100/25 mg Tablets

Arms, Groups and Cohorts

  • Experimental: Generic Test Product
    • Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets
  • Active Comparator: Reference Listed Drug
    • Hyzaar® 100/25 mg Tablets

Clinical Trial Outcome Measures

Primary Measures

  • Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Bioequivalence based on Losartan Cmax.
  • AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Bioequivalence based on Losartan AUC0-t.
  • AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Bioequivalence based on Losartan AUC0-inf.
  • Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Bioequivalence based on Hydrochlorothiazide Cmax.
  • AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Bioequivalence based on Hydrochlorothiazide AUC0-t.
  • AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Bioequivalence based on Hydrochlorothiazide AUC0-inf.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Teva Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
  • Overall Official(s)
    • James D Carlson, Pharm D, Principal Investigator, PRACS Institute, Ltd.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.