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

Phase 1CompletedNCT01751919

Dong-A ST Co., Ltd.37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Myeloid Leukemia Gastrointestinal Stromal Tumor

Interventions

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male volunteers between the ages of 20 to 50 years old * weight more than 55kg and within the range of ±20% of ideal body weight (IBW) * having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination * doctor determines to be suitable as subjects within 3 weeks ago before administration Exclusion Criteria: * Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate * Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin * Creatinine clearance \< 80 mL/min * Gastrointestinal diseases or surgeries that affect absorption of drug * Excessive drinking(exceed 21units/week) * Smoking over 10 cigarettes per day