Bioequivalence Study of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-coated Tablets 300mg/300 mg/600 mg Produced by PT Kimia Farma Tbk Compared to Symfi® Produced by Mylan Laboratories Limited India, Registered by Mylan Specialty L.P. USA
Tahapan Penelitian : Complete
Sponsor:
PT Kimia Farma tbk
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-GZCKNZZ
Tanggal Input Registry : 02-09-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 25-03-2023 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , tmax, half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-coated Tablets 300mg/300 mg/600 mg Produced by PT Kimia Farma Tbk Compared to Symfi® Produced by Mylan Laboratories Limited India, Registered by Mylan Specialty L.P. USA |
| Judul Penelitian Ilmiah | Bioequivalence Study of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-coated Tablets 300mg/300 mg/600 mg Produced by PT Kimia Farma Tbk Compared to Symfi® Produced by Mylan Laboratories Limited India, Registered by Mylan Specialty L.P. USA |
| Jenis Penelitian | Interventional |
| Intervensi | Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-coated Tablets 300mg/300 mg/600 mg Produced by PT Kimia Farma Tbk |
| Jumlah Subyek Penelitian | 28 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: The inclusion criteria for this study include: 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 100- 129 mmHg, diastolic blood pressure 60-84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, body temperatureExclusion Criteria: The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests will be 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 (Pehadoxin Forte Tablet (Isoniazid 400 mg + Vitamin B6 10 mg)); 4) Clinically significant (routine hematology, liver function, kidney function, blood glucose, urinalysis) 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) History or condition that can affect drug kinetics. 11) Use of drugs or dietary supplements no more than 7 days since the start of the study. 12) Participation in previous clinical trials no more than 3 months from the start of the study. 13) 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-150/UN2.F1/ETIK/PPM.00.02/2023 (30 Jan 2023) and S-140/UN2.F1/ETIK/PPM.00.02/2023 ( 20 Feb 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 (lab.equitrust@gmail.com) |