Bioequivalence study of 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica in comparison with the innovator film-coated tablets (Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France).

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-EXER6KO
Tanggal Input Registry : 23-07-2024

25-02-2013
Find out whether the bioavailability of 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica was equivalent to the tablets that produced the innovator (Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France).
 
Bioequivalence study of 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica in comparison with the innovator film-coated tablets (Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France).
Bioequivalence study of 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica in comparison with the innovator film-coated tablets (Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France).
Interventional
Test drug: 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica Reference drug: Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France
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Inclusion Criteria:

1. Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination. 2. Aged 18 - 55 years inclusive. 3. Preferably non-smokers or moderate smokers (less than 10 cigarettes per day). 4. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minutes rest) must be within the following ranges. - Systolic blood pressure : 100 - 120 mmHg - Diastolic blood pressure : 60 - 80 mmHg - Pulse rate : 60 - 90 bpm

Exclusion Criteria:

1. Personal/family history of allergy or hypersensitivity or contraindication to metformin or allied drug. 2. Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the study drug). 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness e.g congestive cardiac failure (heart failure), hepatitis, hypotensive episodes, hyperglycemia, etc. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Clinically significant hematology abnormalities. 7. Clinically significant electrocardiogram (ECG) abnormalities. 8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. 9. Past history of anaphylaxis or angioedema. 10. History of drug or alcohol abuse within 12 months prior to screening for this study. 11. Participation in any clinical trial within the past 90 days. 12. History of any bleeding or coagulative disorders. 13. History of difficulty with difficulty in accessibility of veins in left or right arm. 14. A donation or loss of 500 mL (or more) of blood within 90 days before this study’s first dosing day. 15. Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
20/H2.F1/ETIK/I/2013
Not applicable
PPUK/PPUB number
Kartika Widyanty