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Completed

NCT Number: NCT00953680

Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is a healthy male or female between the ages of 18 and 45 years of age
  • Subject does not smoke

Exclusion criteria

  • Subject has a history of any illness that might pose additional risk to participation or confound the results of the study
  • Subject has a history of hepatitis B or C or significant drug allergies

Treatment and study plan

losartan potassium (+) hydrochlorothiazide (HCTZ)

Drug

Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.

Losartan Potassium

Drug

Single dose losartan 100 mg tablet in one of two treatment periods.

Other names: COZAAR™

Hydrochlorothiazide (HCTZ)

Drug

Single dose HCTZ 12.5 mg capsule in one of two treatment periods.

Other names: MICROZIDE™

Primary outcomes

  1. Area Under the Curve (AUC(0 to Infinity)) of Losartan

    Time frame: 0 to 36 Hours Post Dose

  2. Peak Plasma Concentration (Cmax) for Losartan

    Time frame: 36 Hours Post Dose

    Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.

  3. Area Under the Curve (AUC(0 to Infinity)) of HCTZ

    Time frame: 0 to 30 Hours Post Dose

    Plasma Area Under the Curve, a measure of drug exposure following dosing

  4. Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ

    Time frame: 30 Hours Post Dose

    Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 6, 2009
Registry last updated
Feb 9, 2022

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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