NCT01270984

Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy volunteers.

Detailed description

Healthy volunteers are administrated single-dose over the period I and II (Crossover) of Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg. Every time before and after each medication, PK parameters and safety of Luckyvec 400mg tablet and Glivec 100mg is performed using a blood sample and conducting some tests(Laboratory test, V/S, Physical Examination, etc) respectively.

Conditions

• Chronic Myeloid Leukemia
• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Luckyvec 400mg film coated tablet	•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
DRUG	Glivec 100mg film coated tablet	•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-01-06
• Last updated: 2012-10-31

Locations

1 site across 1 country: South Korea