A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
NCT ID: NCT01751919
Last Updated: 2014-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2012-05-31
2012-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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)
Imatinib mesylate tablet 400 mg, 1 Tablet
Glivec film-coated tablet 100 mg, 4 Tablets
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)
Imatinib mesylate tablet 400 mg, 1 Tablet
Glivec film-coated tablet 100 mg, 4 Tablets
Interventions
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Imatinib mesylate tablet 400 mg, 1 Tablet
Glivec film-coated tablet 100 mg, 4 Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
50 Years
MALE
Yes
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kyungpook National University
Daegu, , South Korea
Countries
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References
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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.
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.
Other Identifiers
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Imatinib_CML_I
Identifier Type: -
Identifier Source: org_study_id
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