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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Drug: Imatinib mesylate tablet 400 mg, 1 Tablet
* Drug: Glivec film-coated tablet 100 mg, 4 Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 (RT)<br>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<br> <br> Drug: Glivec film-coated tablet 100 mg, 4 Tablets<br> <br> |
| Other: Group 2 (TR)<br>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<br> <br> Drug: Glivec film-coated tablet 100 mg, 4 Tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration in plasma (Cmax) of Imatinib mesylate |  | Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose | 
| Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax (Tmax) of Imatinib mesylate |  | Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose | 
| Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate |  | Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose | 
| Terminal Elimination Half-life (t1/2) of Imatinib mesylate |  | Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, GIST