BIOEQUIVALENCE STUDY OF 10 MG AMLODIPINE BESILATE TABLET MANUFACTURED BY PT MEDIKON PRIMA LABORATORIES IN COMPARISON WITH 10 MG NORVASK® TABLET MANUFACTURED BY PT PFIZER INDONESIA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-G974THG
Tanggal Input Registry : 20-08-2024

17-04-2023
AUC0-t and Cmax
AUCinf, t½ and tmax
 
BIOEQUIVALENCE STUDY OF 10 MG AMLODIPINE BESILATE TABLET MANUFACTURED BY PT MEDIKON PRIMA LABORATORIES IN COMPARISON WITH 10 MG NORVASK® TABLET MANUFACTURED BY PT PFIZER INDONESIA
BIOEQUIVALENCE STUDY OF 10 MG AMLODIPINE BESILATE TABLET MANUFACTURED BY PT MEDIKON PRIMA LABORATORIES IN COMPARISON WITH 10 MG NORVASK® TABLET MANUFACTURED BY PT PFIZER INDONESIA
Interventional
AMLODIPINE BESILATE 10 MG TABLET
14
 

Inclusion Criteria:

1. have read the subject information and signed informed consent documents 2. healthy male and female 3. age 18 – 55 years 4. body mass index between 18–25 kg/m2 5. have a normal electrocardiogram 6. blood pressure within normal range (systolic 110-129 mmHg and diastolic 70-80 mmHg) 7. heart rate within normal range (60-100 bpm) 8. with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening 9. agree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout the study

Exclusion Criteria:

1. those who are pregnant and/or nursing condition. 2. those with a history of hypersensitivity to amlodipine, dihydropyridines or other calcium channel blockers or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction 3. those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease 4. those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities 5. those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. 6. those who have participated in any clinical study within 3 months prior to the study (< 90 days) 7. those who have donated or lost 300 mL (or more) of blood within 3 months prior to the study. 8. those who smoke more than 10 cigarettes per day. 9. those with history of travelling to another city within the last 14 days without following health authority regulation 10. those with history of direct contact with a COVID-19 positive person in the subject’s neighborhood within 5 days prior to screening 11. those with history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days 12. those who are positive to SARS CoV-2 antigen test 13. those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential) 14. those with a history of drug or alcohol abuse within 12 months prior to screening for this study 15. those who are unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1408/UN.2.F1/ETIK/PPM.00.02/2022 and S-145/UN.2.F1/ETIK/PPM.00.02/2023
MTA number
PPUK/PPUB number
apt. Juliana, S.Farm., M.Farm