Chronic Myeloid Leukemia Clinical Trial
Official title:
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
1. purpose: To conduct the relative bioavailability study of a single dose and multiple
doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus
Glivec (Novartis Pharma Stein AG).
2. Experimental Design： Two-period crossover design
3. Test drug: imatinib mesylate capsule Reference drug: Glivec
4. Sample size：20
To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20 patients with chronic myeloid leukemia. ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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