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

NCT01568450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-01-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • GL Pharm Tech Corporation

    lead INDUSTRY

Principal Investigators

  • Doo-Yeoun Cho, MD · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568450 on ClinicalTrials.gov