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

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

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
* Drug: losartan potassium
* Drug: hydrochlorothiazide (HCTZ)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: losartan /HCTZ combination tablet<br>single dose losartan 100 mg/HCTZ 12.5 mg combination tablet | Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)<br>* Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.<br>|
| Active Comparator: losartan tablet + HCTZ capsule<br>Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule | Drug: losartan potassium<br>* Single dose losartan 100 mg tablet in one of two treatment periods.<br>* Other names: COZAAR™;Drug: hydrochlorothiazide (HCTZ)<br>* Single dose HCTZ 12.5 mg capsule in one of two treatment periods.<br>* Other names: MICROZIDE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0 to Infinity)) of Losartan |  | 0 to 36 Hours Post Dose | 
| Peak Plasma Concentration (Cmax) for Losartan | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing. | 36 Hours Post Dose | 
| Area Under the Curve (AUC(0 to Infinity)) of HCTZ | Plasma Area Under the Curve, a measure of drug exposure following dosing | 0 to 30 Hours Post Dose | 
| Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing | 30 Hours Post Dose |