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

• Status: Completed
• Trial end date: 2012-08-01

Summary

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

• Phase: Phase 1

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Imatinib Mesylate