Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers

NCT01926548 Phase 1 COMPLETED

This study is designed 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.

Details

Lead sponsor	HK inno.N Corporation
Phase	Phase 1
Status	COMPLETED
Enrolment	28
Start date	2012-02
Completion	2012-06

Conditions

• Healthy

Interventions

• CJ Imatinib mesylate tablet
• Gleevec film-coated tablet 2 x 100mg

Primary outcomes

• maximum concentration, Area under the concentration-time curve from zero to infinity — Blood sampling up to 72hs post dose(16 times).
  Administration of IP : 1day

Countries

South Korea