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Bioequivalence Study of Glimepiride 1mg Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00776490
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Glimepiride 1mg Tablets Not Applicable

Detailed Description:

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on glimepiride comparing glimepiride 1mg tablets of Ranbaxy laboratories limited with Amaryl 1mg tablets of in healthy, adult, human, subjects under fasting conditions.

A total of 32 subjects were entered into this study and 31 subjects completed the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of Glimepiride 1 MG Tablets Under Fasting Conditions
Study Start Date : July 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Glimepiride 1 MG Tablets of ranbaxy
 Drug: Glimepiride 1mg Tablets
Active Comparator: 2
AMARYL® 1 mg tablets
 Drug: Glimepiride 1mg Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776490


Locations
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United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Ranbaxy Laboratories Limited
More Information
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Additional Information:

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Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00776490    
Other Study ID Numbers: 10381501
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008
Keywords provided by Ranbaxy Inc.:
Bioequivalence Glimepiride Tablets
Additional relevant MeSH terms:
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Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
 Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors