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OpenTrials
Completed

NCT Number: NCT01926548

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

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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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CJ Imatinib mesylate tablet

Drug

Gleevec film-coated tablet 2 x 100mg

Drug

Primary outcomes

  1. maximum concentration, Area under the concentration-time curve from zero to infinity

    Time frame: Blood sampling up to 72hs post dose(16 times).

    Administration of IP : 1day

Secondary outcomes

  1. Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity

    Time frame: Blood sampling up to 72hs post dose(16 times).

    Administration of IP : 1 day

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

Open-label, Randomized, Single-dose, 2-way Crossover Study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2013
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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