Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting
Condition: Healthy
Intervention: Glyburide/Metformin 5 mg/500 mg Tablets; Glucovance® 5 mg/500 mg Tablets
Intervention description: 1 x 5 mg/500 mg, single-dose fasting; 1 x 5 mg/500 mg, single-dose fasting
Intervention MeSH terms: Metformin; Glyburide
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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 fasting conditions.
    

Eligibility 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)