NCT01568450

A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GL Pharm Tech Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet. GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxycodone	Oxycodone XL 20mg(20mg once a day, fasted)
DRUG	Oxycodone	Oxycodone XL 20mg/day(20mg once a day, after high fat meal)
DRUG	Oxycodone	Oxycodone 20mg/day (10mg twice a day, fasted)

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-04-02
• Last updated: 2013-01-28

Locations

1 site across 1 country: South Korea