A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

November 11, 2014 updated by: GL Pharm Tech Corporation
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

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
  • Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

  • 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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GL2907
Oxycodone HCl 20mg
Drug: GL2907
once a day
Other Names:
  • Oxycodone HCl 20mg
Active Comparator: Oxycontine CR 10mg
Oxycodone HCl 10mg
Drug: Oxycontine CR 10mg
twice a day
Other Names:
  • Oxycodone HCl 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,ss
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
AUCτ
Time Frame: 24h
Pharmacokinetic of Oxycodone
24h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
t1/2
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
Vz/f
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
CL/F
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
Cmin,ss
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
Cave,ss
Time Frame: 48h
Pharmacokinetic of Oxycodone
48h
degree og fluctuation
Time Frame: 48h

Pharmacokinetic of Oxycodone

(Cmax,ss-Cmin,ss)/Cave,ss
48h
swing
Time Frame: 48h

Pharmacokinetic of Oxycodone

(Cmax,ss-Cmin,ss)/Cmin,ss
48h
R
Time Frame: 48h

Pharmacokinetic of Oxycodone

Accumulation index
48h

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

April 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL2907-102

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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