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Disease Attributes

Neoplasms, Connective Tissue

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Myeloid Leukemia

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Amino Acids

Imatinib Mesylate

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Tyrosine

* Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
* Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)

* Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
* Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)

Imatinib mesylate tablet 400 mg, 1 Tablet

Glivec film-coated tablet 100 mg, 4 Tablets

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

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

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)

Dong-A ST Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)	NCT01751919	Chronic Myeloid... Gastrointestina...	Imatinib mesyla... Glivec film-coa...	20 Years - 50 Years	Dong-A ST Co., Ltd.
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)	NCT01751919	Chronic Myeloid... Gastrointestina...	Imatinib mesyla... Glivec film-coa...	20 Years - 50 Years	Dong-A ST Co., Ltd.

Spots Global Cancer Trial Database for imatinib mesylate tablet 400 mg, 1 tablet