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

NCT01926548 | Completed Phase 1

• 1 other identifier: CJ_IMM_101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• 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).

Study Arms (2)

CJ Imatinib 200mg

EXPERIMENTAL

1 tablet(200mg) a day,PO,QD

Drug: CJ Imatinib mesylate tablet

Gleevec 100mg

ACTIVE COMPARATOR

2 tablet(100mg) a day,PO,QD

Drug: Gleevec film-coated tablet 2 x 100mg

Interventions

CJ Imatinib mesylate tablet DRUG

CJ Imatinib 200mg

Gleevec film-coated tablet 2 x 100mg DRUG

Gleevec 100mg

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 21, 2013
• Study Start: February 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

KR (1)