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Completed

NCT Number: NCT01149473

Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects 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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

About this study

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan potassium/Hydrochlorothiazide

Drug

100/25 mg Tablets

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Teva Pharmaceuticals USA

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jun 23, 2010
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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