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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Single and multiple oral mesylate imatinib capsule 400mg qd
Single and multiple oral Glivec 400mg qd
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, China
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
Time frame: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
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