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 non-fasting conditions.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.