Bioequivalence study of multisourced of amlodipine besylate 10 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia).
Tahapan Penelitian : Complete
PT Dexa Medica
PT Equilab International
Tanggal Input Registry : 17-11-2023
|Tanggal Antisipasi Studi||08-05-2023|
|Outcome Primer||To find out whether the bioavailability of PT Dexa Medica’s formulation of amlodipine besylate was equivalent to that of the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia).|
|Judul Penelitian Popular||Bioequivalence study of multisourced of amlodipine besylate 10 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia).|
|Judul Penelitian Ilmiah||Bioequivalence study of multisourced of amlodipine besylate 10 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia).|
|Intervensi||Test drug: Amlodipine besylate 10 mg tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Norvask® 10 mg Tablet (produced by PT Pfizer Indonesia)|
|Jumlah Subyek Penelitian||24|
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 the 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. Vital signs (after 10 minutes rest) must be 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 contraception during the study.
Exclusion Criteria:1. History of allergy or hypersensitivity or contraindication to amlodipine or other dihydropyridine 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. 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 (especially amlodipine and irbesartan), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
|Nomor Persetujuan Etik||KET-254/UN2.F1/ETIK/PPM.00.02/2023|
|Nomor Persetujuan Material Transfer Agreement||Not applicable|
|Nomor Persetujuan Pelaksanaan Uji Klinik||PPUK/PPUB number|
|Other Study ID Numbers|
|Contact Person||Kartika Widyanty|