Bioequivalence Study of Furosemide 40 mg (Farsiretic® Tablet) Manufactured by PT IFARS Pharmaceutical Laboratories Compared to Furosemide 40 mg (Lasix® Tablet) Manufactured by PT Kalventis Sinergi Farma
Tahapan Penelitian : Complete
Sponsor:
PT IFARS PHARMACEUTICAL LABORATORIES
Mitra Pelaksana:
EQuitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-2DPKY1EQ
Tanggal Input Registry : 21-08-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 14-07-2025 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , tmax, half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Furosemide 40 mg (Farsiretic® Tablet) Manufactured by PT IFARS Pharmaceutical Laboratories Compared to Furosemide 40 mg (Lasix® Tablet) Manufactured by PT Kalventis Sinergi Farma |
| Judul Penelitian Ilmiah | Bioequivalence Study of Furosemide 40 mg (Farsiretic® Tablet) Manufactured by PT IFARS Pharmaceutical Laboratories Compared to Furosemide 40 mg (Lasix® Tablet) Manufactured by PT Kalventis Sinergi Farma |
| Jenis Penelitian | Interventional |
| Intervensi | Furosemide 40 mg (Farsiretic® Tablet) Manufactured by PT IFARS Pharmaceutical Laboratories |
| Jumlah Subyek Penelitian | 24 |
| 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/heart rate for ECG examination 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95-100%, body temperature 36.5-37.5oC, and normal respiratory rate of 12-20/min.Exclusion 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 (Furosemide); 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. The check is conducted using the checksubject.com system based on national identity number. 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-698/UN2.F1/ETIK/PPM.00.02/2025 and S-449/UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Not Specified |
| Contact Person | Bayu Hadi Wahyono, Pharm, B.Pharm, MPH - Study Coordinator (+62 821 2559 0521 - lab.equitrust@gmail.com) |