Pharmacokinetics of Imatinib mesylate tablet 200mg
- Conditions
- Not Applicable
- Registration Number
- KCT0000755
- Lead Sponsor
- CJ CheilJedang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 28
1)Healthy male of 20 to 55 years of age
2)18.5 kg/m2 = BMI = 27 kg/m2
3)A subject who is able to participate whole periods of the study
4)A subject who provides written informed consent voluntarily
1)Systolic blood pressure < 90 or = 140 mmHg, diastolic blood pressure < 60 or = 90 mmHg, or pulse rate >100 beats per minute
2)History of hypersensitivity to the investigational products or to drugs
3)One of the following values in the clinical laboratory test
- AST, ALT, or bilirubin upper than 1.5 times the upper range of normal
- Glomerular filtration rate using MDRD formula less than 80 mL/min
4)Use of the drug which induces or inhibits CYP3A within 30 days before the first investigational product administration
5)Use of caffeine-containing beverages (coffee, tea, or coke), grapefruit or orange juice more than 4 cups a day
6)Smoking more than 20 cigarettes per day
7)Use of alcohol more than 140 g per week (12° wine 1 glass (125 mL) = 12.0 g, 4° beer 1 glass (250 mL) = 8 g, 20° soju 0.5 bottle (180 mL) = 28.8 g)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUClast of imatinib
- Secondary Outcome Measures
Name Time Method tmax, t1/2, AUClast of imatinib