Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-CPE6Y84
Tanggal Input Registry : 05-04-2023

31-03-2022
To find out whether the bioavailability of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica is equivalent to the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects
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Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects
Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects
Interventional
Test drug Clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica Reference drug: Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period.
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Inclusion Criteria:

1. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation. 3. Aged 18 - 55 years inclusive. 4. Preferably non-smokers or smoke less than 10 cigarettes per day. 5. Body mass index within 18 to 25 kg/m2. 6. Normal clotting time (CT) (1 – 6 minutes) and normal bleeding time (BT) (1 - 3 minutes). 7. Vital signs (after 10 minutes rest) must be within the following ranges: - Systolic blood pressure: 100 - 129 mmHg - Diastolic blood pressure: 60 - 84 mmHg - Pulse rate: 60 - 90 bpm. 8. Willing to practice abstention or contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to clopidogrel or allied drug. 2. Pregnant or lactating female (urinary pregnancy test was 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. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, 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. Positive result for COVID-19 rapid antigen test. 7. Clinically significant hematology abnormalities. 8. Clinically significant electrocardiogram (ECG) abnormalities. 9. 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. 10. Past history of anaphylaxis or angioedema. 11. History of drug or alcohol abuse within 12 months prior to screening for this study. 12. Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day. 13. History of any bleeding or coagulative disorders. 14. Presence of difficulty in accessibility of veins in left or right arm. 15. A donation or significant blood loss within 90 days before this study’s first dosing day. 16. 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.
 
KET-1176/UN2.F1/ETIK/PPM.00.02/2021
BE. 693/EQL/2021
Liana Wijaya, M.Biomed ; apt. Kartika Widyanty, S. Farm.