CClinicalTrials.gg
Sign In
CompletedNCT01751919Updated Oct 1, 2014

A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

A Phase 1 interventional study of Imatinib mesylate tablet 400 mg, 1 Tablet and Glivec film-coated tablet 100 mg, 4 Tablets in Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study summary

  1. Investigational Product

    1. Imatinib mesylate tablet 400 mg
    2. Glivec film-coated tablet 100 mg (Comparator)

  2. Expected target disease

    1. chronic myeloid leukemia
    2. Gastrointestinal stromal tumors

  3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

    1. 36 healthy subjects, 2 groups (18 subjects/group)
    2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
    3. wash-out period : 14 days

  4. Evaluation on pharmacokinetics(PKs) and safety

    1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
    2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test

  5. Statistical method

    1. Demography Characteristics
    2. Pharmacokinetic parameters
    3. Safety data
02

Conditions studied

  • Chronic Myeloid Leukemia
  • Gastrointestinal Stromal Tumor

Keywords

  • CML
  • GIST
03

In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's enrollment of 37 is below the median of 44 across 743 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy male volunteers between the ages of 20 to 50 years old
  • weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
  • Creatinine clearance \< 80 mL/min
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Excessive drinking(exceed 21units/week)
  • Smoking over 10 cigarettes per day
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Other
    Group 1 (RT)

    * Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) * Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)

    Drug: Imatinib mesylate tablet 400 mg, 1 Tablet · Drug: Glivec film-coated tablet 100 mg, 4 Tablets

  • Other
    Group 2 (TR)

    * Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) * Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)

    Drug: Imatinib mesylate tablet 400 mg, 1 Tablet · Drug: Glivec film-coated tablet 100 mg, 4 Tablets

Interventions

  • DrugImatinib mesylate tablet 400 mg, 1 Tablet
  • DrugGlivec film-coated tablet 100 mg, 4 Tablets
06

What researchers measure

Primary outcomes

  1. Maximum concentration in plasma (Cmax) of Imatinib mesylate

    Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

  2. Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate

    Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

Secondary outcomes

  1. Time to Cmax (Tmax) of Imatinib mesylate

    Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

  2. Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate

    Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

  3. Terminal Elimination Half-life (t1/2) of Imatinib mesylate

    Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose

07

Study locations

1 site
  • Kyungpook National University
    Daegu, Korea, Republic of
08

References and documents

Publications

  • Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodriguez P, Marquez S, Guarneri C, Estevez-Parrillo FT, Laurenz M, Estevez-Carrizo FE. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clin Ther. 2009 Oct;31(10):2224-32. doi: 10.1016/j.clinthera.2009.10.009. PubMed 19922893 ↗
  • Nikolova Z, Peng B, Hubert M, Sieberling M, Keller U, Ho YY, Schran H, Capdeville R. Bioequivalence, safety, and tolerability of imatinib tablets compared with capsules. Cancer Chemother Pharmacol. 2004 May;53(5):433-8. doi: 10.1007/s00280-003-0756-z. PubMed 15132131 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01751919
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Dec 18, 2012
Start date
May 2012
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Oct 1, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia, Myelogenous, Chronic, BCR-ABL Positive→

Other studies from this sponsor

Dong-A ST Co., Ltd.

Start the discussion