BIOEQUIVALENCE STUDY OF RIFAMPICIN 75 MG/ISONIAZID 50 MG (FDC-2) DISPERSIBLE TABLETS MANUFACTURED BY PT KIMIA FARMA TBK IN COMPARISON WITH RIFINAH ® 150 MG/100 MG TABLETS MANUFACTURED BY SANOFI S.R.L,ANAGNI, ITALY

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-ZFG64K8
Tanggal Input Registry : 28-08-2024

12-02-2024
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
BIOEQUIVALENCE STUDY OF RIFAMPICIN 75 MG/ISONIAZID 50 MG (FDC-2) DISPERSIBLE TABLETS MANUFACTURED BY PT KIMIA FARMA TBK IN COMPARISON WITH RIFINAH ® 150 MG/100 MG TABLETS MANUFACTURED BY SANOFI S.R.L,ANAGNI, ITALY
BIOEQUIVALENCE STUDY OF RIFAMPICIN 75 MG/ISONIAZID 50 MG (FDC-2) DISPERSIBLE TABLETS MANUFACTURED BY PT KIMIA FARMA TBK IN COMPARISON WITH RIFINAH ® 150 MG/100 MG TABLETS MANUFACTURED BY SANOFI S.R.L,ANAGNI, ITALY
Interventional
RIFAMPICIN 75 MG/ISONIAZID 50 MG (FDC-2) DISPERSIBLE TABLETS
26
 

Inclusion Criteria:

1. Subjects had read the subject information and able to give written informed consenparticipation in the study and comply with the study protocol/procedures.; 2. Subjects healthy male and female; 3. Subjects age range 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 rang - Systolic blood pressure: 90 – 129 mmHg - 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

Exclusion Criteria:

1. those who were pregnant and/or nursing condition ; 2. those with a history of hypersensitivity or contraindication to rifampicin or isoniazid, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction; 3. 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 ; 4. those who had history or presence of jaundice; 5. those who had history or presence of diabetes mellitus; 6. those who had history of previous treatment for tuberculosis (TB) or was suspected from TB; 7. those who recently use of oral (2 weeks) or IV (2 – 3 months) antibiotics to assure normal bowel flora at study start.; 8. those who had history or presence of hematology disorder, coagulation disorder, tendency of bruise easily, or clinically significant hematology abnormalities; 9. those who disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period; 10. 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 ; 11. those who had participated in any clinical study within the past 90 days prior to the study; 12. those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study; 13. those who smoker; 14. those who not receiving the complete primary SARS CoV-2 vaccine; 15. those who were positive result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine); 16. those with history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days; 17. those who with 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 ; 18. those who positive result for HIV, HbsAg, and HCV tests (to be kept confidential); 19. those who had history of drug or alcohol abuse within 12 months prior to screening for this study; 20. those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1605/UN2.F1/ETIK/PPM.00.02/2023(2023-11-17(amandemen 2 januari 2024))
Not applicable
PPUK/PPUB number
Nabila Mudin Sutanto, Pharm