BIOEQUIVALENCE STUDY OF RIFAMPICIN 600 MG FILMCOATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK, JAKARTA IN COMPARISON WITH RIFADIN® (2 x 300 MG) CAPSULES MANUFACTURED BY SANOFI S.R.L, ITALY

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
No Registry
INA-XGWK68E
Tanggal Input Registry : 07-08-2024

08-05-2024
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
BIOEQUIVALENCE STUDY OF RIFAMPICIN 600 MG FILMCOATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK, JAKARTA IN COMPARISON WITH RIFADIN® (2 x 300 MG) CAPSULES MANUFACTURED BY SANOFI S.R.L, ITALY
BIOEQUIVALENCE STUDY OF RIFAMPICIN 600 MG FILMCOATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK, JAKARTA IN COMPARISON WITH RIFADIN® (2 x 300 MG) CAPSULES MANUFACTURED BY SANOFI S.R.L, ITALY
Interventional
RIFAMPICIN 600 MG FILM COATED TABLETS
26
 

Inclusion Criteria:

1. Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures.; 2. Subjects healthy male and female; 3. Subjects’ age ranges from 18 – 55 years; 4. Subjects’ body mass index between 18 – 25 kg/m2; 5. Subjects had a normal electrocardiogram. 6. Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range : Systolic blood pressure: 90 – 129 mmH, Diastolic blood pressure: 60 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute (based on ESC - ESH Guidelines for the Management of Arterial Hypertension (2018)); 7. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening; 8. Subjects had received the complete primary SARS CoV-2 vaccine; 9. Subjects had negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine)

Exclusion Criteria:

1. those who were pregnant and/or nursing women (for women); 2. those with history of contraindication or hypersensitivity to rifampicin, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significantallergic disease, or allergic reaction; 3. those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric /intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease; 4. those with history or presence of any coagulation disorder, tendency of bruise easily, or clinically significant hematology abnormalities; 5. those with a history or presence of jaundice; 6. those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period; 7. those who 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; 8. those who participated in any clinical study within the past 90 days prior to the study; 9. those who donated or losing 300 mL (or more) of blood within 3 months prior to the study; 10. those who were smoker; 11. those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within 14 days prior to screening; 12. those who had 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; 13. those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential; 14. those who had history of drug or alcohol abuse within 12 months prior to screening for this study; 15. those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-274/UN2.F1/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Nabila Mudin Sutanto, Pharm