Bioequivalence Study of Bisoprolol Fumarate 10 mg (Concaprol® 10) Film-Coated Tablets Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Indonesia Tbk, Jakarta Under License From Merck KGaA, Germany

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-D683KD6
Tanggal Input Registry : 25-01-2023

22-08-2022
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of Bisoprolol Fumarate 10 mg (Concaprol® 10) Film-Coated Tablets Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Indonesia Tbk, Jakarta Under License From Merck KGaA, Germany
Bioequivalence Study of Bisoprolol Fumarate 10 mg (Concaprol® 10) Film-Coated Tablets Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Indonesia Tbk, Jakarta Under License From Merck KGaA, Germany
Eksperimental
Subjects were given a single dose of 10 mg Bisoprolol of test drug or of reference drug with 240 mL of water
14
 

Inclusion Criteria:

The inclusion criteria were healthy subjects who/with: - had read the subject information and signed informed consent documents - healthy male and female - age range from 18 – 55 years - body mass index between 18 – 25 kg/m2 - had a normal electrocardiogram - had the blood pressure within normal range (systolic 100 - 120 mmHg and diastolic 70 – 80 mmHg) - had the heart rate within normal range (80 – 100 bpm) - had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - had acceptance to use protection (condom) before any intercourse with their spouse during the study

Exclusion Criteria:

This study was not eligible for: - those who were pregnant and/or nursing condition - those with a history of contraindication or hypersensitivity to bisoprolol, or other beta blockers agents, or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction - those with a history of contraindication or special precautions to bisoprolol, including a history of psoriasis and a history of diabetes mellitus - those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities - those who had bronchial asthma or chronic obstructive pulmonary disease (COPD) - those with a history or presence of psoriasis - those with a history or presence of diabetes mellitus - those who were 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 - those who had participated in any clinical study within 3 months prior to the study (< 90 days). - those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study. - those who were smoker - those with a history of travelling to another city within the last 14 days - those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood - those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days - those who were positive to SARS CoV-2 antigen test - those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential). - those with a history of drug or alcohol abuse within 12 months prior to screening for this study. - those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-585/UN2.F1/ETIK/PPM.00.02/2022
N.A
RG.01.02.321.07.22.01024/UB
580/STD/PML/2020
Nabila Mudin S