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Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Glyburide/Metformin 5 mg/500 mg Tablets (Drug); Glucovance® 5 mg/500 mg Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Eric Bicrell, M.D., Principal Investigator, Affiliation: Anapharm

Summary

The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under fed conditions.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax (Maximum Observed Concentration) - Glyburide

AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide

AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide

Cmax (Maximum Observed Concentration) - Metformin

AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin

AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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: 1. Condom + spermicide 2. Diaphragm + spermicide 3. Intrauterine contraceptive device (placed at least 4 weeks prior to study drug administration)

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec GIV2K8, Canada
Additional Information

Starting date: February 2003
Last updated: September 1, 2009

Page last updated: August 23, 2015

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