Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
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.
Interventional
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Area Under Curve (AUC) Time Frame: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
9 months
Yes
Shen Zh xiang, doctor
Principal Investigator
Shanghai Jiaotong University School of Medicine Ruijin Hospital
China: Ethics Committee
YMTN-1.0
NCT01795716
September 2012
June 2013
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