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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CJ Imatinib mesylate tablet; Drug: Gleevec film-coated tablet 2 x 100mg

• Registration Number: NCT01926548
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-20
• Last Update Submitted: 2013-08-20
• Study First Posted: 2013-08-21
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CJ Imatinib 200mg	CJ Imatinib mesylate tablet	1 tablet(200mg) a day,PO,QD
Gleevec 100mg	Gleevec film-coated tablet 2 x 100mg	2 tablet(100mg) a day,PO,QD

Primary Outcome Measures

Name	Time	Method
maximum concentration, Area under the concentration-time curve from zero to infinity	Blood sampling up to 72hs post dose(16 times).	Administration of IP : 1day

Secondary Outcome Measures

Name	Time	Method
Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity	Blood sampling up to 72hs post dose(16 times).	Administration of IP : 1 day

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of