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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)

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)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01751919
Study type Interventional
Source Dong-A ST Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 2012
Completion date August 2012
View Details
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