Glimepiride 4 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Glimepiride 4 mg Tablets; AMARYL® 4 mg Tablets
Intervention description: 1 x 4 mg, single-dose fasting; 1 x 4 mg, single-dose fasting
Intervention MeSH terms: Glimepiride
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
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 glimepiride 4 mg
      tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA
      Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking
      subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects selected for this study will be non-smokers at least 18 years of age.
             Subjects will have a BMI (body mass index) of 30 or less.

          -  Each subject shall be given a general physical examination within 28 days of
             initiation of the study. Such examination includes, but is not limited to, blood
             pressure, general observations, and history.

        Each female subject will be given a serum pregnancy test as part of the pre-study screening
        process.

        Adequate blood and urine samples should be obtained within 28 days before beginning of the
        first period and at the end of the trial for clinical laboratory measurements.

        Clinical laboratory measurements will include the following:

          -  Hematology: hemoglobin, hematocrit, red blood cell count, platelets, whit blood cell
             count (with differential).

          -  Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and
             alkaline phosphatase.

          -  Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult
             blood, and cells.

          -  HIV Screen: pre-study only.

          -  Hepatitis-B, C Screen: pre-study only.

          -  Drugs of Abuse Screen: pre-study and at each check-in. Subjects will be selected if
             all above are normal.

        Exclusion Criteria:

          -  Subjects with a significant recent history of chronic alcohol consumption, drug
             addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease,
             tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible
             for this study.

          -  Subjects whose clinical laboratory test values are greater than 20% outside the normal
             range may be retested. If the clinical values are outside the range on retesting, the
             subject will not be eligible to participate in the study unless the clinical
             investigator deems the result to not be significant.

          -  Subjects who have a history of allergic responses to the class of drug being tested
             will be excluded from the study.

          -  Subjects who use tobacco in any form will not be eligible to participate in the study.
             Three months abstinence is required.

          -  All subjects will have urine samples assayed for the presence of drugs of abuse as
             part of the clinical laboratory screening procedures and at each dosing period
             check-in. Subjects found to have urine concentrations of any of the tested drugs will
             not be allowed to participate.

          -  Subjects should not have donated blood and/or plasma for at least thirty (30) days
             prior to the first dosing of the study.

          -  Subjects who have taken any investigational drug within thirty (30) days prior to the
             first dosing of the study will not be allowed to participate.

          -  Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant
             during the study will not be allowed to participate. Female subjects of childbearing
             potential must either abstain from sexual intercourse or use a reliable barrier method
             (e.g. condom, IUD) of contraception during the course of the study (first dosing until
             last blood collection) or they will not be allowed to participate. Female subjects who
             have used hormonal oral contraceptives within 14 days of dosing or implanted or
             injected hormonal contraceptives within 180 days of dosing 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.