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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00953680

First received: August 4, 2009

Last updated: September 10, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2009

Last Updated Date

September 10, 2010

Start Date ^ICMJE

April 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area Under the Curve (AUC(0 to Infinity)) of Losartan [ Time Frame: 0 to 36 Hours Post Dose ] [ Designated as safety issue: No ]
Peak Plasma Concentration (Cmax) for Losartan [ Time Frame: 36 Hours Post Dose ] [ Designated as safety issue: No ]
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.
Area Under the Curve (AUC(0 to Infinity)) of HCTZ [ Time Frame: 0 to 30 Hours Post Dose ] [ Designated as safety issue: No ]
Plasma Area Under the Curve, a measure of drug exposure following dosing
Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ [ Time Frame: 30 Hours Post Dose ] [ Designated as safety issue: No ]
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

Original Primary Outcome Measures ^ICMJE

Area under the curve (AUC(0 to infinity)) of losartan following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 36 hours postdose ] [ Designated as safety issue: No ]
Peak plasma concentration (Cmax) of losartan following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 36 hours postdose ] [ Designated as safety issue: No ]
Area under the curve (AUC(0 to infinity)) of HCTZ following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 30 hours postdose ] [ Designated as safety issue: No ]
Peak plasma concentration (Cmax) of HCTZ following single dose administration of losartan/HCTZ or losartan and HCTZ [ Time Frame: Through 30 hours postdose ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00953680 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.
Drug: losartan potassium
Single dose losartan 100 mg tablet in one of two treatment periods.

Other Name: COZAAR™
Drug: hydrochlorothiazide (HCTZ)
Single dose HCTZ 12.5 mg capsule in one of two treatment periods.

Other Name: MICROZIDE™

Study Arm (s)

Active Comparator: losartan /HCTZ combination tablet
single dose losartan 100 mg/HCTZ 12.5 mg combination tablet

Intervention: Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
Active Comparator: losartan tablet + HCTZ capsule
Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
Interventions:
- Drug: losartan potassium
- Drug: hydrochlorothiazide (HCTZ)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00953680

Other Study ID Numbers ^ICMJE

2009_628, MK0954A-306

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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