Bioequivalence Pilot Study of Ketoconazole 200 mg Tablet Produced by PT Kimia Farma Tbk Compared to Ketoconazole Tablet, USP 200 mg ex Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel
Tahapan Penelitian : Complete
Sponsor:
PT Kimia Farma Tbk
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-XYCP4C4
Tanggal Input Registry : 02-09-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 15-08-2023 |
Outcome Primer | AUC0-t , Cmax |
Outcome Skunder | AUC0-inf , tmax, half life |
Descriptive Information | |
Judul Penelitian Popular | Bioequivalence Pilot Study of Ketoconazole 200 mg Tablet Produced by PT Kimia Farma Tbk Compared to Ketoconazole Tablet, USP 200 mg ex Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel |
Judul Penelitian Ilmiah | Bioequivalence Pilot Study of Ketoconazole 200 mg Tablet Produced by PT Kimia Farma Tbk Compared to Ketoconazole Tablet, USP 200 mg ex Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel |
Jenis Penelitian | Interventional |
Intervensi | Ketoconazole 200 mg Tablet by PT. Kimia Farma Tbk |
Jumlah Subyek Penelitian | 12 |
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 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: The exclusion criteria for this study include: 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 (Ketoconazole); 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-1116/UN2.F1/ETIK/PPM.00.02/2023 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
Other Study ID Numbers | |
Contact Person | Nungky Tri Yunica, S.T (lab.equitrust@gmail.com) |