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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01751919

Enrollment

Registered

2012-12-18

Start date

2012-05-31

Completion date

2012-08-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor

Keywords

CML, GIST

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

Interventions

DRUGImatinib mesylate tablet 400 mg, 1 Tablet

DRUGGlivec film-coated tablet 100 mg, 4 Tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026