BE Study of Metformin GSK 850mg

NCT01710540 | Completed Phase 2

• 1 other identifier: 116728
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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 850 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 850 mg tablets of Merck Sante, France, in healthy adult human male subjects under fasting condition.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Cmax, Tmax, AUC0-t, AUC0-∞, AUC%_Extrap, Kel and t1/2

  Statistical analyses will be done using SAS® version 9.2 or higher. Analysis of variance \[ANOVA\] for log-transformed pharmacokinetic parameters \[Cmax, AUC0-t and AUC0-∞\] and two one-sided tests \[Schuirmann\] for bioequivalence will be performed. Power, ratio and 90% confidence interval for log-transformed pharmacokinetic parameters - Cmax, AUC0-t and AUC0-∞ will be calculated. The calculated 90% Confidence Interval for the test to reference ratio of Metformin should fall within the range of 80%-125% for log transformed Cmax, AUC0-t and AUC0-∞ for the conclusion of bioequivalence.

  7days

Secondary Outcomes (1)

• Safety profile

  14 days

Study Arms (2)

Metformin GSK 850mg

OTHER

open label, crossover, two period, two treatment, two sequence, single dose of Metformin 850mg

Other: Metformin GSK 850mg; Other: Gluocophage 850mg

Glucophage 850mg

OTHER

open label, crossover, two period, two treatment, two sequence, single dose

Other: Metformin GSK 850mg; Other: Gluocophage 850mg

Interventions

Metformin GSK 850mg OTHER

EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 850 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 850 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION

Glucophage 850mg; Metformin GSK 850mg

Gluocophage 850mg OTHER

EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 850 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 850 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION

Glucophage 850mg; Metformin GSK 850mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 bilirubin \</=1.5xULN (isolated bilirubin \>1.5xULN 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 19, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 19, 2012

Record last verified: 2012-10