Bioequivalence Study of 10 mg Amlodipine Besylate Tablets (Intervask) Manufactured by PT Interbat in Comparison with 10 mg Norvask® Tablets Manufactured by PT Pfizer Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-825632G
Tanggal Input Registry : 04-10-2023

29-05-2023
Cmax, AUCt
 
Bioequivalence Study of 10 mg Amlodipine Besylate Tablets (Intervask) Manufactured by PT Interbat in Comparison with 10 mg Norvask® Tablets Manufactured by PT Pfizer Indonesia.
Bioequivalence Study of 10 mg Amlodipine Besylate Tablets (Intervask) Manufactured by PT Interbat in Comparison with 10 mg Norvask® Tablets Manufactured by PT Pfizer Indonesia.
Interventional
Intervask 10 mg tablet
18
 

Inclusion Criteria:

Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures, Healthy male and female, Age between 18 – 55 years, Body Mass Index (BMI) between 18–25 kg/m2, Having a normal electrocardiogram, 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, Having no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Accept to use contraception (condom) during intercourse with subjects’ spouse within study period.

Exclusion Criteria:

Pregnant and/or nursing woman, Having 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, significant allergic disease, allergic reaction, Having history or present 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 and any cardiovascular disease, Having history or presence of any coagulation disorder or clinically significant hematology abnormalities, 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, Participated in any clinical study within the past 90 days prior to the study, Having donate or lost 300 ml (or more) of blood within 3 months prior to the study, Smoking habit with more than 10 cigarettes a day, History of travelling to another city within the last 14 days without following health authority regulation, History of direct contact with a COVID-19 positive person in the subject’s neighborhood within 5 days prior to screening, History or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days, Positive result to SARS CoV-2 antigen test, Positive result to HIV, HBsAg, and HCV tests (to be kept confidential), History of drug or alcohol abuse within 12 months prior to screening for this study, Unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-504/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
726/STD/PML/2023
Nabila Mudin S