Overview

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
Target enrollment:
0
Participant gender:
Male
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
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
Imatinib Mesylate
Criteria
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