A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers (GL2907-101)

January 25, 2013 updated by: GL Pharm Tech Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggido
      • Suwon, Gyeonggido, Korea, Republic of
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GL2907 XL 20mg (Oxycodone 20mg, fasted)
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)
EXPERIMENTAL: GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)
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)
ACTIVE_COMPARATOR: Oxycontin CR 10mg (Oxycodone 10mg, fasted)
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GL Pharm Tech Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (ESTIMATE)

April 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL2907-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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