Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
- Registration Number
- NCT01149473
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
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
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Generic Test Product Losartan potassium/Hydrochlorothiazide Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets Reference Listed Drug Losartan potassium/Hydrochlorothiazide Hyzaar® 100/25 mg Tablets
- Primary Outcome Measures
Name Time Method Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) Blood samples collected over a 48 hour period. Bioequivalence based on Hydrochlorothiazide Cmax.
AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) Blood samples collected over a 48 hour period. Bioequivalence based on Losartan AUC0-t.
AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) Blood samples collected over a 48 hour period. Bioequivalence based on Losartan AUC0-inf.
AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) Blood samples collected over a 48 hour period. Bioequivalence based on Hydrochlorothiazide AUC0-t.
AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) Blood samples collected over a 48 hour period. Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) Blood samples collected over a 48 hour period. Bioequivalence based on Losartan Cmax.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRACS Institute, Ltd.
🇺🇸Fargo, North Dakota, United States