NCT01751919

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Chronic Myeloid Leukemia
• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	Imatinib mesylate tablet 400 mg, 1 Tablet
DRUG	Glivec film-coated tablet 100 mg, 4 Tablets

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-12-18
• Last updated: 2014-10-01

Locations

1 site across 1 country: South Korea