Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Losartan potassium/Hydrochlorothiazide
* Drug: Losartan potassium/Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Generic Test Product<br>Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets | Drug: Losartan potassium/Hydrochlorothiazide<br>* 100/25 mg Tablets<br>|
| Active Comparator: Reference Listed Drug<br>Hyzaar® 100/25 mg Tablets | Drug: Losartan potassium/Hydrochlorothiazide<br>* 100/25 mg Tablets<br>* Other names: Hyzaar®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Losartan Cmax. | Blood samples collected over a 48 hour period. | 
| AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on Losartan AUC0-t. | Blood samples collected over a 48 hour period. | 
| AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on Losartan AUC0-inf. | Blood samples collected over a 48 hour period. | 
| Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Hydrochlorothiazide Cmax. | Blood samples collected over a 48 hour period. | 
| AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on Hydrochlorothiazide AUC0-t. | Blood samples collected over a 48 hour period. | 
| AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on Hydrochlorothiazide AUC0-inf. | Blood samples collected over a 48 hour period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects