Bioequivalence study of Nilotinib 200mg capsule

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2022
INTERVENTION: Intervention 1: Intervention group: single dose, one oral capsule 200mg(Tasigna) manufactured by Novartis, as a reference product. Intervention 2: Intervention group: Single dose, one oral Nitagxha 200 mg capsule manufactured by Zistdaru Danesh company as test product. CONDITION: This study is performed on healthy volunteers.. PRIMARY OUTCOME: Drug plasma concentration. Timepoint: Immediately before drug consumption and , 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 and 72 h 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: ea579cefaba4e44282237ee7534e9d468d996b27
First added on: Aug 26, 2024