Bioequivalence study of Abirateron 500mg tablet

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2023
INTERVENTION: Intervention 1: Intervention group: single dose, one oral tablet Zytiga 500mg manufactured by Janssen Biotech as a reference product. Intervention 2: Intervention group: Single dose, one oral Bratiga 500 mg tablet manufactured by Abidi company as test product. CONDITION: This study is performed on healthy volunteers and drug concentration in plasma is determined.. PRIMARY OUTCOME: Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48 and 72h after drug administration. Method of measurement: Liquid Chromatography Mass‐Mass. SECONDARY OUTCOME: Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration ‐time. Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded. INCLUSION CRITERIA: General Health (Liver, Heart, and Kidney) Body Mass Inde X(18‐28) Informed consent Age (18‐55 years old)
Epistemonikos ID: d7349eee32f7405cc297ce29d15b2c640463fc78
First added on: Aug 28, 2024