Chronic Myeloid Leukemia Clinical Trial
Official title:
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)
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
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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