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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Losartan potassium/Hydrochlorothiazide

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Generic Test Product; Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets	Drug: Losartan potassium/Hydrochlorothiazide; 100/25 mg Tablets; Other Names: Hyzaar®
Active Comparator: Reference Listed Drug; Hyzaar® 100/25 mg Tablets	Drug: Losartan potassium/Hydrochlorothiazide; 100/25 mg Tablets; Other Names: Hyzaar®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: James D Carlson, Pharm D, PRACS Institute, Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: June 22, 2010
• First Posted (Estimated): June 23, 2010

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: B046515