In-vivo Bioequivalence Test of Abiraterone tablet 500 mg Actero Middle East with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany)

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2022
INTERVENTION: Intervention 1: Intervention group: One test tablet (Abiraterone tablet 500 mg produced by Actro Middle East Pharma) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. Intervention 2: Control group: One Reference tablet ZYTIGA® 500 mg, Janssen Biotech, Germany will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of drug in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. CONDITION: Bio equivalence test. PRIMARY OUTCOME: Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:5, 4, 6, 8, 10, 24, 48, 72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector. INCLUSION CRITERIA: General health Body mass index between18‐28 Informed consent Being at the age of 18‐60 years old
Epistemonikos ID: c59cf4ac20a0af8154f8c6910c5f8fff57bdbe87
First added on: Aug 25, 2024