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)
Phase 1
20 Years
50 Years
20 Years
50 Years
Not Enrolling
Male
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
Male
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum concentration in plasma (Cmax) of Imatinib mesylate
Outcome Time Frame:
Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Safety Issue:
No
Authority:
South Korea : Korea Food and Drug Administration
Study ID:
Imatinib_CML_I
NCT ID:
NCT01751919
Start Date:
May 2012
Completion Date:
August 2012
Related Keywords:
- Chronic Myeloid Leukemia
- Gastrointestinal Stromal Tumor
- CML
- GIST
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Gastrointestinal Stromal Tumors
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