Bioequivalence study of amlodipine besylate 10 mg tablet (Ervask Tablet) produced by PT Erlangga Edi Laboratories in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia)

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-F6ZC8FP
Tanggal Input Registry : 02-11-2023

15-05-2023
AUC0-72h dan Cmax
 
Bioequivalence study of amlodipine besylate 10 mg tablet (Ervask Tablet) produced by PT Erlangga Edi Laboratories in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia)
Bioequivalence study of amlodipine besylate 10 mg tablet (Ervask Tablet) produced by PT Erlangga Edi Laboratories in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia)
Interventional
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one of the test drug (amlodipine 10 mg tablet produced by PT Erlangga Edi Laboratories) or one of the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia) with 200 mL of water.
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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 the 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 contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to amlodipine or other dihydropyridine 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 antigen rapid 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 to 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
 
KET-204/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
BE. 783/EQL/2023
Ronal Simanjuntak – PT Equilab International