to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Male volunteers in the age between 20 and 55 years old

• Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

• Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2

• Available for the entire study period

• Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

• History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease

• Clinically significant vital sign

• SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg

• DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg

• 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

• AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range

• Estimated GFR(Glomerular Filtration Rate) < 80 mL/min

• History of caffeine, alcohol, smoking abuse

• caffeine > 4 cups/day

• grapefruit juice > 4 cups/day

• smoking > 20 cigarettes/day

• alcohol > 140g/week

• 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