BIOEQUIVALENCE STUDY OF KONBLOBET-1 5 MG FILM- COATED TABLETS MANUFACTURED BY PT KONIMEX IN COMPARISON WITH CONCOR® 5 MG FILM-COATED TABLETS MANUFACTURED BY PT MERCK TBK, JAKARTA, INDONESIA UNDER LICENSE FROM MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Not Sepcified
No Registry
INA-6XTBPE4H
Tanggal Input Registry : 30-11-2024

05-09-2024
Cmax, AUCt
 
BIOEQUIVALENCE STUDY OF KONBLOBET-1 5 MG FILM- COATED TABLETS MANUFACTURED BY PT KONIMEX IN COMPARISON WITH CONCOR® 5 MG FILM-COATED TABLETS MANUFACTURED BY PT MERCK TBK, JAKARTA, INDONESIA UNDER LICENSE FROM MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY
BIOEQUIVALENCE STUDY OF KONBLOBET-1 5 MG FILM- COATED TABLETS MANUFACTURED BY PT KONIMEX IN COMPARISON WITH CONCOR® 5 MG FILM-COATED TABLETS MANUFACTURED BY PT MERCK TBK, JAKARTA, INDONESIA UNDER LICENSE FROM MERCK HEALTHCARE KGAA, DARMSTADT, GERMANY
Interventional
Bisoprolol Fumarate 5 mg Film-Coated Tablets
20
 

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/m 2 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: 70 – 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.

Exclusion Criteria:

1. Pregnant and/or nursing woman 2. Having history of hypersensitivity or contraindication to bisoprolol or other 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. Having history or presence of bronchial asthma or chronic obstructive pulmonary disease (COPD) 6. Having history or presence of psoriasis 7. Having history or presence of diabetes mellitus 8. Disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period. 9. 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. 10. Participate in any clinical study within the past 90 days prior to the study. 11. Donated or losing 300 mL (or more) of blood within 3 months prior to the study. 12. Smoker. 13. History of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days prior to the screening. 14. 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. 15. Positive to HIV, HBsAg, and HCV tests (to be kept confidential). 16. History of drug or alcohol abuse within 12 months prior to screening for this study. 17. Unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1123/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Anton Hidayat, Pharm