BE Study of Metformin GSK 500mg

• Status: Completed
• Trial end date: 2012-05-18
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study.

To demonstrate the bioequivalence of Metformin 500 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 500 mg tablets of MERCK SANTE in healthy adult human male subjects under fasting condition and to monitor the safety of the study subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Metformin

Criteria

Inclusion Criteria

• Healthy adult male human subjects within the age range of 18 to 45 years inclusive.

• Weight not less than 50 kg.

• Normal BMI [18.5 to 24.99 kg/m2 inclusive].

• Willingness and capability to provide written informed consent to participate in the study.

• Free of significant diseases or clinically significant abnormal findings based on medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].

• Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.

• AST, ALT, alkaline phosphatase and bilirubin1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

• ECG normal for morphology and measurements. QTcB or QTcF < 450 msec or QTc < 480 msec in subjects with Bundle Branch Block, based on an average from three ECGs obtained over a brief recording period.

• Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed below. This criterion must be followed from the time of the first dose of study medication until one week of last dose administration.

• Condom plus partner use of a highly effective contraceptive such as occlusive cap (diaphragm or cervical/vault cap) plus spermicidal agent (foam/gel/film/cream/suppository), oral contraceptive, injectable progesterone, implant of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device.

OR

• Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria

• History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro-intestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease.

• History or presence of significant:

• Alcohol dependence, alcohol abuse during past one year.

• Drug abuse [Marijuana [THC], Cocaine, Morphine, Benzodiazepines, Barbiturates and Amphetamine] for the last 6 months.

• Smoking of more than 5 cigarettes per day or consumption of other forms of tobacco containing products.

• Asthma, urticaria or other allergic type reactions after taking aspirin or any other drug.

• Ulceration or history of gastric and / or duodenal ulcer.

• Jaundice in the past 6 months.

• Bleeding disorder.

• Allergy to the test drug or any drug chemically similar to the drug or to the excipients of the products under investigation.

• Donation of 500 mL or more blood within 8 weeks prior to receiving the first dose of study drug.

• Subjects who have participated in another clinical study in the past 3 months prior to commencement of this study.

• Any difficulty in accessibility of forearm veins for cannulation or blood sampling.

• Refusal to abstain from food for at least 10 h prior to drug administration and for at least 4 h post dose in each period.

• Refusal to abstain from fluid for at least 1 h prior to and 1 h post each dose except 20 % glucose solution given after dosing.

• Positive breath alcohol test result found on the day of check-in.

• Positive urine test result for drug of abuse found on the day of check-in.

• History of difficulty in swallowing tablet.

• Use of any concomitant medication [including over-the-counter products, vitamins etc.] for 14 days preceding the study drug administration.

• Use of drugs which induce or inhibit metabolizing enzymes within 30 days prior to receiving the first dose of study medication.

Other Eligibility Criteria Considerations To assess any potential impact on subject eligibility with regard to safety, the investigator must refer to the product data sheet for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the product being used in this study.