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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01568450

Acronym

GL2907-101

Enrollment

Registered

2012-04-02

Start date

2012-03-31

Completion date

2012-04-30

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Oxycodone, controlled release formulation

Brief 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.

Interventions

DRUGOxycodone

Oxycodone XL 20mg(20mg once a day, fasted)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 20\ 45 years old, Healthy Adult Male Subject * ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%

Exclusion criteria

* ALT or AST \> 1.25(Upper Normal Range) * Total Bilirubin \> 1.5 (Upper Normal Range) * BUN or Creatinine \> Normal Range * Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg

Design outcomes

Primary

Measure	Time frame	Description
Cmax	48hr	Pharmacokinetic of Oxycodone
AUC(0-24h)	24 hr	Pharmacokinetic of Oxycodone

Secondary

Measure	Time frame	Description
Vz/F	48 hr	Pharmacokinetic of Oxycodone
Tmax	48 hr	Pharmacokinetic of Oxycodone
Safety Monitoring	27 days	Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test
CL/F	48 hr	Pharmacokinetic of Oxycodone
t1/2	48 hr	Pharmacokinetic of Oxycodone

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026