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BE STUDY OF METFORMIN GSK 1000mg (BA/BE 199/11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01710553
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 1000 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 1000 mg tablets of Merck Sante, France in healthy adult human male subjects under fasting condition

Condition or disease Intervention/treatment Phase
Diabetic Foot Other: Glucophage 1000mg Other: Metformin GSK 1000mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, SINGLE ORAL DOSE, BIOEQUIVALENCE STUDY OF METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 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
Study Start Date : July 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Metformin GSK 1000mg
open label, crossover, two period, two treatment, two sequence, single dose of Metformin 1000mg
Other: Glucophage 1000mg
EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 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

Other: Metformin GSK 1000mg
EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 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 1000mg
open label, crossover, two period, two treatment, two sequence, single dose of Glucophage 1000mg to asset bioequivalence
Other: Glucophage 1000mg
EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 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

Other: Metformin GSK 1000mg
EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 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




Primary Outcome Measures :
  1. Cmax, Tmax, AUC0-t, AUC0-∞, AUC%_Extrap, Kel and t1/2 [ Time Frame: 7 days ]
    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


Secondary Outcome Measures :
  1. Safety profile [ Time Frame: 14 days ]
    The Principal Investigator will monitor safety data throughout the course of the study. A qualified medical doctor experienced in conducting bioequivalence study will be available during housing in the clinical center. Subjects will be monitored throughout the study period for occurrence of any adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710553


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01710553    
Other Study ID Numbers: 116729
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs