- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00834340
Glimepiride 4 mg Tablets Under Fasting Conditions
A Relative Bioavailability Study of Glimepiride 4 mg Tablets Under Fasting Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77042
- Novum Pharmaceutical Research Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glimepiride
Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
|
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
|
1 x 4 mg, single-dose fasting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 24 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 24 hour period
|
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time Frame: Blood samples collected over 24 hour period
|
Bioequivalence based on AUCinf
|
Blood samples collected over 24 hour period
|
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
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 24 hour period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Solomon G. Ghide, M.D., Novum Pharmaceutical Research Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B036501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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