Overview

Bioequivalence Study of Glimepiride 1mg Tablets Under Fasting Conditions

Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to compare the relative bioavailability of glimepiride 1 mg tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fasting conditions.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Laboratories Limited
Treatments:
Glimepiride
Criteria
Inclusion Criteria:

- Source of Subjects: Non-institutionalized subjects consisting of members of the
community at large.

- Characterization of Study Group.

- All subjects selected for this study will be at least 18 years of age.

- 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. At the end of the study, the subjects will have an exit evaluation
consisting of interim history, global evaluation, and clinical laboratory
measurements.

- 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, and white
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 check-in each study period

- Subjects will be selected if all above are normal.

- Electrocardiograms of all participating subjects will be recorded before initiation of
the study and filed with each subject's case report forms.

Exclusion Criteria:

- Subjects with a history of chronic alcohol consumption I,(during past 2 years), drug
addiction, or serious gastrointestinal, renal, hepatic or cardiovascular
disease,tuberculosis, epilepsy, asthma (during past 5 years), 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
should be excluded from the study.

- 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 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 child bearing
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.

- Subjects who have used implanted or injected hormonal contraceptives anytime during
the 6 months prior to study dosing, or used oral hormonal contraceptives within 14
days before 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.