NCT01568450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

March 19, 2012

Last Update Submit

January 25, 2013

Conditions

Healthy

Keywords

Oxycodone, controlled release formulation

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Pharmacokinetic of Oxycodone

    48hr

  • AUC(0-24h)

    Pharmacokinetic of Oxycodone

    24 hr

Secondary Outcomes (5)

  • Tmax

    48 hr

  • t1/2

    48 hr

  • Vz/F

    48 hr

  • CL/F

    48 hr

  • Safety Monitoring

    27 days

Study Arms (3)

GL2907 XL 20mg (Oxycodone 20mg, fasted)

EXPERIMENTAL
Drug: Oxycodone

GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)

EXPERIMENTAL
Drug: Oxycodone

Oxycontin CR 10mg (Oxycodone 10mg, fasted)

ACTIVE COMPARATOR
Drug: Oxycodone

Interventions

OxycodoneDRUG

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

GL2907 XL 20mg (Oxycodone 20mg, fasted)

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AJOU University Hospital

Suwon, Gyeonggido, South Korea

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Doo-Yeoun Cho, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

April 2, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

KR(1)