Status:
COMPLETED
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Eligibility Criteria
Inclusion
- 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
- 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 Subjects with positive or inconclusive results will be withdrawn from the study.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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01149473
Start Date
March 1 2004
End Date
April 1 2004
Last Update
August 20 2024
Active Locations (1)
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1
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104