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This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ Imatinib 200mg | Experimental | 1 tablet(200mg) a day,PO,QD |
|
| Gleevec 100mg | Active Comparator | 2 tablet(100mg) a day,PO,QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ Imatinib mesylate tablet | Drug |
| ||
| Gleevec film-coated tablet 2 x 100mg |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration, Area under the concentration-time curve from zero to infinity | Administration of IP : 1day | Blood sampling up to 72hs post dose(16 times). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity | Administration of IP : 1 day | Blood sampling up to 72hs post dose(16 times). |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
Clinically significant vital sign
History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
History of clinically significant allergies, including imatinib
Clinical laboratory test values are outside the accepted normal range
History of caffeine, alcohol, smoking abuse
Participated in a previous clinical trial within 3 months prior to dosing
Donated blood within 60 days prior to dosing
Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
Subjects considered as unsuitable based on medical judgement by investigators
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| Drug |
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