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A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

Dong-A ST Co., Ltd. · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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1. Investigational Product 1. Imatinib mesylate tablet 400 mg 2. Glivec film-coated tablet 100 mg (Comparator) 2. Expected target disease 1. chronic myeloid leukemia 2. Gastrointestinal stromal tumors 3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study 1. 36 healthy subjects, 2 groups (18 subjects/group) 2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet)) 3. wash-out period : 14 days 4. Evaluation on pharmacokinetics(PKs) and safety 1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2 2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test 5. Statistical method 1. Demography Characteristics 2. Pharmacokinetic parameters 3. Safety data
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