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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumor

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01751919

Imatinib_CML_I

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Group 1 (RT)

Other group

Description:

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

Treatment:

Drug: Imatinib mesylate tablet 400 mg, 1 Tablet

Drug: Glivec film-coated tablet 100 mg, 4 Tablets

Group 2 (TR)

Other group

Description:

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

Treatment:

Drug: Imatinib mesylate tablet 400 mg, 1 Tablet

Drug: Glivec film-coated tablet 100 mg, 4 Tablets