Back to resultsA Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
Primary Purpose
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Imatinib mesylate tablet 400 mg, 1 Tablet
Glivec film-coated tablet 100 mg, 4 Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring CML, GIST
Eligibility Criteria
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:
- 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
Sites / Locations
- Kyungpook National University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1 (RT)
Group 2 (TR)
Arm Description
Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
Outcomes
Primary Outcome Measures
Maximum concentration in plasma (Cmax) of Imatinib mesylate
Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate
Secondary Outcome Measures
Time to Cmax (Tmax) of Imatinib mesylate
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate
Terminal Elimination Half-life (t1/2) of Imatinib mesylate
Full Information
NCT ID
NCT01751919
First Posted
December 14, 2012
Last Updated
September 29, 2014
Sponsor
Dong-A ST Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01751919
Brief Title
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
Official Title
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigational Product
Imatinib mesylate tablet 400 mg
Glivec film-coated tablet 100 mg (Comparator)
Expected target disease
chronic myeloid leukemia
Gastrointestinal stromal tumors
Study design : Randomized, open-label, single dose, two-period, two-way, crossover study
36 healthy subjects, 2 groups (18 subjects/group)
2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
wash-out period : 14 days
Evaluation on pharmacokinetics(PKs) and safety
PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
safety : adverse events, physical examination, vital sign, ECG, Laboratory test
Statistical method
Demography Characteristics
Pharmacokinetic parameters
Safety data
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
Keywords
CML, GIST
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (RT)
Arm Type
Other
Arm Description
Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
Arm Title
Group 2 (TR)
Arm Type
Other
Arm Description
Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate tablet 400 mg, 1 Tablet
Intervention Type
Drug
Intervention Name(s)
Glivec film-coated tablet 100 mg, 4 Tablets
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Kyungpook National University
City
Daegu
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
19922893
Citation
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.
Results Reference
background
PubMed Identifier
15132131
Citation
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.
Results Reference
background
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A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
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