Bioequivalence Study of Isoniazid 300 mg Tablet Produced by PT Kimia Farma Tbk Compared to Isoniazid 3x100 mg Tablet Produced by Reimser Pharma GMBH
Tahapan Penelitian : Complete
Sponsor:
PT Kimia Farma Tbk
Mitra Pelaksana:
In conducting this research, we collaborated with several partners, there are :
1. Ambulance Gawat Darurat Dinas Kesehatan DKI Jakarta to provide ambulance and paramedical services for emergencies
2. Clinical Laboratory - PT Kimia Farma Diagnostika to carry out medical check-ups
3. Mintohardjo Naval Hospital as a reference for subjects who experienced an adverse event
4. Competent phlebotomist for blood sampling during the study, and
5. Doctor for monitoring vital signs of research subjects
No Registry
INA-KMFN90P
Tanggal Input Registry : 28-07-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-04-2023 |
| Outcome Primer | 1. Maximum plasma concentration (Cmax) [ Time Frame: before dosing (0 hour), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, and 24.00 after drug administration ] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 24 hours (AUCt) [ Time Frame: before dosing (0 hour), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, and 24.00 after drug administration ] 90% Confidence Interval (80-125) |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Isoniazid 300 mg Tablet Produced by PT Kimia Farma Tbk Compared to Isoniazid 3x100 mg Tablet Produced by Reimser Pharma GMBH |
| Judul Penelitian Ilmiah | Bioequivalence Study of Isoniazid 300 mg Tablet Produced by PT Kimia Farma Tbk Compared to Isoniazid 3x100 mg Tablet Produced by Reimser Pharma GMBH |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was Isozid® (Isoniazid 100 mg) tablet manufactured by: Riemser Pharma GmbH An der Wlek 7-17493 Greifswald-Insel Riems, batch number 001060, expired date on May 2025. The test drug was Isoniazid 300 mg tablet manufactured by PT. Kimia Farma Tbk, batch number I20102NX, manufacturing date 14 October 2022, Expired date 13 October 2024. On the sampling day, the subject took one dose of Isoniazid manufactured of either formulation (reference or test) as per the randomization scheme with 220 ml water in sit position. |
| Jumlah Subyek Penelitian | 26 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 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: 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 (Isoniazid); 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. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-50/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Nungky Tri Yunica, S.T |