Bioequivalence Study of Bisoprolol 5 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to Concor® 5 mg Film-Coated Tablet Produced by PT Merck Tbk Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-CE3S97A
Tanggal Input Registry : 30-11-2023

10-10-2023
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration), at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 7.00, 9.00, 12.00, 18.00, 24.00 and 30 hours after drug administration (16 time points)] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 30 hours (AUCt) [[time points : 0 hours (before drug administration), at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 7.00, 9.00, 12.00, 18.00, 24.00 and 30 hours after drug administration (16 time points)] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Bisoprolol 5 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to Concor® 5 mg Film-Coated Tablet Produced by PT Merck Tbk Indonesia
Bioequivalence Study of Bisoprolol 5 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to Concor® 5 mg Film-Coated Tablet Produced by PT Merck Tbk Indonesia
Interventional
The reference drug was Concor® 5 mg Film-coated Tablet produced by PT Merck Tbk, Jakarta, Indonesia, batch number E1006323, manufacturing date on Juny 16th 2022, expired date on Juny 14th 2025. The test drug was Bisoprolol Fumarate 5 mg Film-Coated Tablet produced by PT Kimia Farma Tbk, batch number B01F3394, manufacturing date Juny 14th 2023, Expired date Juny 14th 2025. Starting at 07.00 on the first day, the subjects are given the investigational drug (1 tablet of 5 mg Bisoprolol) or the comparator drug (1 tablet of 5 mg Concor®) with 220 mL of water while sitting. The subjects are asked to maintain an upright position, either standing or sitting, for 1 hour after drug administration.
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Inclusion Criteria:

The inclusion criteria for this study include: 1) Signed informed consent; 2) Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination); 3) Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4) Age between 18-55 years; 5) Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2); 6) Vital signs within the following ranges: systolic blood pressure 110-129 mmHg, diastolic blood pressure 70-84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95-100%, and normal respiratory rate of 12-20/min.

Exclusion Criteria:

The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests was performed during screening and prior to the administration of the investigational or comparator drug; 3) History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Bisoprolol); 4) Clinically significant hematological abnormalities; 5) Abnormal electrocardiogram (ECG); 6) Difficulty accessing veins in the left or right arm; 7) History of significant ongoing clinically or medically significant chronic or acute illness; 8) History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9) Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV). 10) Positive rapid antigen test results for SARS-CoV-2 (if the BE study is conducted during a pandemic). 11) History or condition that can affect drug kinetics. 12) Use of drugs or dietary supplements no more than 7 days since the start of the study. 13) Participation in previous clinical trials no more than 3 months from the start of the study. 14) Blood donation or blood loss of more than 300 ml within 3 months from the start of the study.
 
KET-1082/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T