A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
- Conditions
- Chronic Myeloid LeukemiaGastrointestinal Stromal Tumor
- Interventions
- Registration Number
- NCT01751919
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 37
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 (RT) Imatinib mesylate tablet 400 mg, 1 Tablet * Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) * Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) Group 2 (TR) Imatinib mesylate tablet 400 mg, 1 Tablet * Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) * Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) Group 1 (RT) Glivec film-coated tablet 100 mg, 4 Tablets * Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) * Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) Group 2 (TR) Glivec film-coated tablet 100 mg, 4 Tablets * Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) * Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Kyungpook National University
🇰🇷Daegu, Korea, Republic of