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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 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: Hyzaar®
    • 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 Hydroclorothiazide(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.

Secondary Measures

  • Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.
  • AUC0-t of Losartan Carboxy Acid(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.
    • Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.
  • AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
    • Time Frame: Blood samples collected over a 48 hour period.
    • Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

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.

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