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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014