Pharmacokinetics of Imatinib mesylate tablet 200mg

Open-label, randomized, single-dose, 2-way crossover study to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000755

Enrollment

Registered

2013-05-29

Start date

2012-02-01

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : test drug - CJ Imatinib mesylate tablet 200 mg (imatinib 200 mg) reference drug - Gleevec film-coated tablet 100 mg (imatinib 100 mg)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Healthy male of 20 to 55 years of age 2)18.5 kg/m2 = BMI = 27 kg/m2 3)A subject who is able to participate whole periods of the study 4)A subject who provides written informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1)Systolic blood pressure 100 beats per minute 2)History of hypersensitivity to the investigational products or to drugs 3)One of the following values in the clinical laboratory test - AST, ALT, or bilirubin upper than 1.5 times the upper range of normal - Glomerular filtration rate using MDRD formula less than 80 mL/min 4)Use of the drug which induces or inhibits CYP3A within 30 days before the first investigational product administration 5)Use of caffeine-containing beverages (coffee, tea, or coke), grapefruit or orange juice more than 4 cups a day 6)Smoking more than 20 cigarettes per day 7)Use of alcohol more than 140 g per week (12° wine 1 glass (125 mL) = 12.0 g, 4° beer 1 glass (250 mL) = 8 g, 20° soju 0.5 bottle (180 mL) = 28.8 g)

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast of imatinib	—

Secondary

Measure	Time frame
tmax, t1/2, AUClast of imatinib	—

Countries

Korea, Republic of

Contacts

Public ContactJin Ah Jung

Samsung Medical Center

Outcome results