Bioequivalence Study of Amlodipine Besylate Equivalent to Amlodipine 10 mg Tablets Manufactured by PT Mutiara Mukti Farma in Comparison with Norvask® 10 mg Tablets Manufactured by PT Pfizer Indonesia - Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-64DGMOO6
Tanggal Input Registry : 23-04-2025

01-07-2024
AUC0-t, Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of Amlodipine Besylate Equivalent to Amlodipine 10 mg Tablets Manufactured by PT Mutiara Mukti Farma in Comparison with Norvask® 10 mg Tablets Manufactured by PT Pfizer Indonesia - Indonesia.
Bioequivalence Study of Amlodipine Besylate Equivalent to Amlodipine 10 mg Tablets Manufactured by PT Mutiara Mukti Farma in Comparison with Norvask® 10 mg Tablets Manufactured by PT Pfizer Indonesia - Indonesia.
Interventional
Amlodipine 10 mg
16
 

Inclusion Criteria:

1. Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures. 2. Healthy male and female. 3. Age between 18 – 55 years. 4. Body Mass Index (BMI) between 18–25 kg/m2. 5. Having a normal electrocardiogram. 6. Resting vital signs (after 10 – 15 minutes of resting) are within the following ranges: - Systolic blood pressure: 110 – 129 mmHg - Diastolic blood pressure: 70 – 84 mmHg - Pulse/Heart rate: 60 – 100 beats per minute. 7. Have no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. 8. Have received the complete primary SARS CoV-2 vaccine. 9. Negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine).

Exclusion Criteria:

1. Pregnant and/or nursing woman. 2. Having history of contraindication or hypersensitivity to amlodipine, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction. 3. Having history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease. 4. Having history or presence of any coagulation disorder or clinically significant hematology abnormalities. 5. Disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period. 6. Using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day. 7. Participated in any clinical study within the past 90 days prior to the study. 8. Donated or lost 300 mL (or more) of blood within 3 months prior to the study. 9. Smoking habit with more than 10 cigarettes a day. 10. History of direct contact with a COVID-19 positive person in the subject’s neighborhood within 14 days prior to screening. 11. History or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days. 12. Positive to HIV, HBsAg, and HCV tests (to be kept confidential). 13. History of drug or alcohol abuse within 12 months prior to screening for this study. 14. Unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-295/UN2.FI/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
RG.01.02.321.10.23.02130/UB
Yanto, S.Farm