Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
Condition: Healthy
Intervention: Losartan potassium/Hydrochlorothiazide; Losartan potassium/Hydrochlorothiazide
Intervention description: 100/25 mg Tablets; 100/25 mg Tablets
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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.
    

Eligibility criteria:

        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.