Bioequivalence Study of Ketoconazole 200 mg Tablets (Omegzole 200 mg) Manufactured by PT Mutiara Mukti Farma in Comparison with Ketoconazole 200 mg Tablets Manufactured by Taro Pharmaceutical Industries Ltd., Israel, distributed by Taro Pharmaceuticals U.S.A., Inc., United States

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-8F34TC3
Tanggal Input Registry : 29-08-2024

04-11-2023
AUC0-t, Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of Ketoconazole 200 mg Tablets (Omegzole 200 mg) Manufactured by PT Mutiara Mukti Farma in Comparison with Ketoconazole 200 mg Tablets Manufactured by Taro Pharmaceutical Industries Ltd., Israel, distributed by Taro Pharmaceuticals U.S.A., Inc., United States
Bioequivalence Study of Ketoconazole 200 mg Tablets (Omegzole 200 mg) Manufactured by PT Mutiara Mukti Farma in Comparison with Ketoconazole 200 mg Tablets Manufactured by Taro Pharmaceutical Industries Ltd., Israel, distributed by Taro Pharmaceuticals U.S.A., Inc., United States
Interventional
Ketoconazole 200 mg Tablets
44
 

Inclusion Criteria:

1. Subjects had read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures. 2. Subjects healthy male and female 3. Subjects age range from 18 – 55 years. 4. Subjects’ body mass index between 18 – 25 kg/m2 5. Subjects had a normal electrocardiogram. 6. Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range - Systolic blood pressure: 90 – 129 mmHg - Diastolic blood pressure: 60 – 84 mmHg - Pulse/Heart rate: 60 – 100 beats per minute (based on ESC - ESH Guidelines for the Management of Arterial Hypertension (2018)) 7. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

1. those who were pregnant and/or nursing women 2. those with a history of hypersensitivity or contraindication to ketoconazole, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction 3. those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease 4. those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities 5. those who disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period 6. those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day 7. those who had participated in any clinical study within the past 90 days prior to the study 8. those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study 9. those who smoking habit with more than 10 cigarettes a day 10. those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood with in the last 14 days 11. those with a history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days 12. those who was positive result for SARS CoV-2 antigen test 13. those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential) 14. those with a history of drug or alcohol abuse within 12 months prior to screening for this study. 15. those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1124/UN2.FI/ETIK/PPM.00.02/2023 2023-09-01
Not applicable
PPUK/PPUB number
No.: RG.01.02.321.10.23.02130/UB
Yanto