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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01149473
First received: June 21, 2010
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Losartan potassium/Hydrochlorothiazide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Bioequivalence based on Hydrochlorothiazide AUC0-inf.


Enrollment: 80
Study Start Date: March 2004
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Generic Test Product
Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets
Drug: Losartan potassium/Hydrochlorothiazide
100/25 mg Tablets
Active Comparator: Reference Listed Drug
Hyzaar® 100/25 mg Tablets
Drug: Losartan potassium/Hydrochlorothiazide
100/25 mg Tablets
Other Name: Hyzaar®

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149473

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm D PRACS Institute, Ltd.
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01149473     History of Changes
Other Study ID Numbers: B046515
Study First Received: June 21, 2010
Results First Received: August 16, 2010
Last Updated: August 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Hydrochlorothiazide
Losartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 16, 2014