- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835991
Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed
Randomized, 2-Way Crossover, Bioequivalence Study of Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets and Glucovance® 5 mg/500 mg Film-Coated Tablets in Healthy Subjects Under Fed 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
-
-
Quebec
-
Sainte-Foy, Quebec, Canada, GIV2K8
- Anapharm Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects will be females and/or males, non-smokers, 18 years of age and older.
Exclusion Criteria:
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive urine drug screen at screening.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
- Subjects with BMI less than or equal to 30.0.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- History of allergic reactions to glyburide or to metformin or other related drugs (e.g. chlorpropamide, gliclazide, tolbutamide, furosemide, sulfamethoxazole, sulfadiazine and sulfisoxazole).
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- History or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
- Any history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as supplement) within 7 days prior to administration of study medication except for topical products without systemic absorption.
- Positive alcohol breath test at screening. subjects who have used tobacco in any form within the 90 days preceding study drug administration.
- Intolerance to venipuncture.
- Any food allergy, intolerance, restriction, or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows: less than 300 mL of whole blood within 30 days or; 300 mL to 500 mL of whole blood within 45 days or; more than 500 mL of whole blood within 56 days.
- Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- History of metabolic acidosis, congestive heart failure and myocardial infarction.
- Breast-feeding subjects.
- Positive urine pregnancy test at screening (performed on all females).
Female subjects of childbearing potential who have had unprotected sexual intercourse with any non-steril male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. The acceptable methods of contraception are:
- Condom + spermicide
- Diaphragm + spermicide
- Intrauterine contraceptive device (placed at least 4 weeks prior to study drug administration)
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: Glyburide Metformin
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
|
1 x 5 mg/500 mg, single-dose fed
|
Active Comparator: Glucovance®
Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
|
1 x 5 mg/500 mg, single-dose fed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax (Maximum Observed Concentration) - Glyburide
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 36 hour period
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-inf
|
Blood samples collected over 36 hour period
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 36 hour period
|
Cmax (Maximum Observed Concentration) - Metformin
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 36 hour period
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-inf
|
Blood samples collected over 36 hour period
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 36 hour period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Bicrell, M.D., Anapharm
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
- 02350
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Glyburide/Metformin 5 mg/500 mg Tablets
-
Teva Pharmaceuticals USACompleted
-
Actavis Inc.Completed
-
Actavis Inc.Completed
-
Actavis Inc.Completed
-
Teva Pharmaceuticals USACompleted
-
Teva Pharmaceuticals USACompleted
-
Mylan Pharmaceuticals IncCompleted
-
Mylan Pharmaceuticals IncCompleted
-
Shandong Suncadia Medicine Co., Ltd.Not yet recruiting
-
Boehringer IngelheimEli Lilly and CompanyCompleted