Glimepiride 4 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834340
First received: January 30, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Glimepiride 4 mg Tablets
Drug: AMARYL® 4 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Glimepiride 4 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
  • AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2003
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glimepiride
Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
Drug: Glimepiride 4 mg Tablets
1 x 4 mg, single-dose fasting
Active Comparator: Amaryl®
Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
Drug: AMARYL® 4 mg Tablets
1 x 4 mg, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834340

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Solomon G. Ghide, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00834340     History of Changes
Other Study ID Numbers: B036501
Study First Received: January 30, 2009
Results First Received: June 22, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014