Bioequivalence study of trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Mahakam Beta Farma in comparison with the comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) when administered under fed condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-9EMC7TQ
Tanggal Input Registry : 24-05-2024

11-12-2023
AUC0-t dan Cmax
 
Bioequivalence study of trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Mahakam Beta Farma in comparison with the comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) when administered under fed condition in healthy subjects
Bioequivalence study of trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Mahakam Beta Farma in comparison with the comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) when administered under fed condition in healthy subjects
Interventional
The participating subjects were given orally either one test drug (trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Mahakam Beta Farma) or one comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) 30 minutes after the subjects have consumed a standardized breakfast meal in the first day of each period with approximately 200 mL of water at ambient temperature.
20
 

Inclusion Criteria:

1. Able to participate, communicate well with the investigators and would 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. Non-smokers, 5. Body mass index within 18 to 25 kg/m2, 6. Vital signs (after 10 minutes rest) were within the following ranges: • Systolic blood pressure : 110 – 129 mmHg • Diastolic blood pressure : 70 – 84 mmHg • Pulse rate : 60 – 90 bpm, 7. Willing to practice abstention or non-hormonal contraception during the study

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to trimetazidine or allied drugs, 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. 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 calculated from the last visit until this study’s first dosing day, 12. History of any bleeding or coagulative disorders, 13. Presence of difficulty in accessibility of veins in left or right arm, 14. A donation or significant blood loss within 90 days before this study’s first dosing day, 15. Intake of any prescription drug (especially trimetazidine and antihypertensive drug), non prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day, 16. History of parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome and other related movement disorders, 17. Having creatinine clearance (CrCl) ≤60 mL/min at screening
 
KET-1518/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
BE. 803/EQL/2023
Ronal Simanjuntak – PT Equilab International