NCT01779492

Brief Summary

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

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 Apr 2013

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

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

January 28, 2013

Last Update Submit

November 11, 2014

Conditions

Healthy

Keywords

Oxycodone, controlled release formulation

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss

    Pharmacokinetic of Oxycodone

    48h

  • AUCτ

    Pharmacokinetic of Oxycodone

    24h

Secondary Outcomes (9)

  • Tmax

    48h

  • t1/2

    48h

  • Vz/f

    48h

  • CL/F

    48h

  • Cmin,ss

    48h

  • +4 more secondary outcomes

Study Arms (2)

GL2907

EXPERIMENTAL

Oxycodone HCl 20mg

Drug: GL2907

Oxycontine CR 10mg

ACTIVE COMPARATOR

Oxycodone HCl 10mg

Drug: Oxycontine CR 10mg

Interventions

GL2907DRUG

once a day

Also known as: Oxycodone HCl 20mg
GL2907
Oxycontine CR 10mgDRUG

twice a day

Also known as: Oxycodone HCl 10mg
Oxycontine CR 10mg

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • ALT or AST \> 1.25 times (Upper Normal Range)
  • Total Bilirubin \> 1.5 times (Upper Normal Range)
  • CPK \> 2 times (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

January 28, 2013

First Posted

January 30, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

KR(1)