NCT01504984

Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers

An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Samyang Biopharmaceuticals Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.

Detailed description

Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg. Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SYO-1126	Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
DRUG	Glivec film coated tab 4T(400mg)	Imatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover)

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-01-06
• Last updated: 2012-06-12

Locations

1 site across 1 country: South Korea