Bioequivalence Study of Ketoconazole 200 mg (Solinfec® Tablet) Produced by PT IFARS Pharmaceutical Laboratories Compared to Ketoconazole 200 mg Tablet, USP Produced by Taro Pharmaceutical Industries Ltd.
Tahapan Penelitian : Complete
Sponsor:
PT. IFARS PHARMACEUTICAL LABORATORIES
Mitra Pelaksana:
EQuitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-92E25FGN
Tanggal Input Registry : 20-12-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 04-11-2024 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , tmax, half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Ketoconazole 200 mg (Solinfec® Tablet) Produced by PT IFARS Pharmaceutical Laboratories Compared to Ketoconazole 200 mg Tablet, USP Produced by Taro Pharmaceutical Industries Ltd. |
| Judul Penelitian Ilmiah | Bioequivalence Study of Ketoconazole 200 mg (Solinfec® Tablet) Produced by PT IFARS Pharmaceutical Laboratories Compared to Ketoconazole 200 mg Tablet, USP Produced by Taro Pharmaceutical Industries Ltd. |
| Jenis Penelitian | Interventional |
| Intervensi | Ketoconazole 200 mg (Solinfec® Tablet) Produced by PT IFARS Pharmaceutical Laboratories |
| Jumlah Subyek Penelitian | 30 |
| 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 (Ketoconazole); 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-1282/UN2.F1/ETIK/PPM.00.02.2024 and S-651/UN2.F1/ETIK/PPM/00/02/2024 |
| 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 - Co-Investigator (+62 821 2559 0521 - lab.equitrust@gmail.com) |