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

Organon

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ); Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00953680

0954A-306

2009_628

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

losartan /HCTZ combination tablet

Active Comparator group

Description:

single dose losartan 100 mg/HCTZ 12.5 mg combination tablet

Treatment:

Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)

losartan tablet + HCTZ capsule

Active Comparator group

Description:

Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule

Treatment:

Drug: hydrochlorothiazide (HCTZ)

Drug: losartan potassium