Bioequivalence Study of 10 mg Amlodipine Besilate Caplets Produced by PT. Harbat Farma in Comparison with Norvask® 10 mg Tablets Manufactured by PT. Pfizer Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
No Registry
INA-445XLCA
Tanggal Input Registry : 02-10-2024

03-01-2024
AUC0-t, Cmax, tmax
 
Bioequivalence Study of 10 mg Amlodipine Besilate Caplets Produced by PT. Harbat Farma in Comparison with Norvask® 10 mg Tablets Manufactured by PT. Pfizer Indonesia
Bioequivalence Study of 10 mg Amlodipine Besilate Caplets Produced by PT. Harbat Farma in Comparison with Norvask® Tablets Manufactured by PT. Pfizer Indonesia
Interventional
Amlodipine Besilate caplets Produced by PT Harbat Farma
14
 

Inclusion Criteria:

Gave a written informed consent, Healthy subjects, both sexes, age between 18 to 55 years old, Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2), Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate(60-90 bpm), Acceptable medical history and physical examination, Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR), Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine, Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria), Normal cardiovascular function was proven by electrocardiogram (ECG) result, Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C(anti HCV), HIV (anti HIV), Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine, Negative result for pregnancy test (was done for female subjects at screening, before period I and before period II of the study), Subject had either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for COVID-19 rapid antigen test at screening. Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.

Exclusion Criteria:

Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted, Pregnant women or nursing mother, Had history of hepatic, cardiovascular, gastrointestinal or renal disease, Had history or condition of heart failure, such as haemodynamically unstable heart failure after acute myocardial infarction, Had history or condition of hepatic failure or impaired hepatic function, Had history or condition of severe hypotension, Had history or condition of shock including cardiogenic shock, Had history or condition of obstruction of the outflow tract of the left ventricle (e.g.high grade aortic stenosis), Hypersensitivity to amlodipine, other dihydropyridines or similar medication, History of alcohol, drug abuse within 12 months prior to screening for this study, Received any other medications within fourteen days prior to the start of the study, Participated in any clinical study within 3 months after the date of completion, Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study, Had symptoms related to COVID-19 (e.g. fever, cough, cold, sore throat, or anosmia) or close contact with COVID-19 patients within fourteen days prior to the start of the study.
 
KET-1078/UN2.FI/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
BE15-23 Version 1
apt. Windy Lusthom, S.Si - Study Director