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

This study is not yet open for participant recruitment.

Verified February 2013 by GL Pharm Tech Corporation

Sponsor:

Information provided by (Responsible Party):

GL Pharm Tech Corporation

ClinicalTrials.gov Identifier:

NCT01779492

First received: January 28, 2013

Last updated: February 18, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2013

Last Updated Date

February 18, 2013

Start Date ^ICMJE

April 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cmax,ss [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
AUCτ [ Time Frame: 24h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01779492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tmax [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
t1/2 [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
Vz/f [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
CL/F [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
Cmin,ss [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
Cave,ss [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone
degree og fluctuation [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone

(Cmax,ss-Cmin,ss)/Cave,ss
swing [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone

(Cmax,ss-Cmin,ss)/Cmin,ss
R [ Time Frame: 48h ] [ Designated as safety issue: No ]
Pharmacokinetic of Oxycodone

Accumulation index

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: GL2907
once a day

Other Name: Oxycodone HCl 20mg
Drug: Oxycontine CR 10mg
twice a day

Other Name: Oxycodone HCl 10mg

Study Arm (s)

Experimental: GL2907
Oxycodone HCl 20mg

Intervention: Drug: GL2907
Active Comparator: Oxycontine CR 10mg
Oxycodone HCl 10mg

Intervention: Drug: Oxycontine CR 10mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01779492

Other Study ID Numbers ^ICMJE

GL2907-102

Has Data Monitoring Committee

Responsible Party

GL Pharm Tech Corporation

Study Sponsor ^ICMJE

GL Pharm Tech Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Doo-Yeoun Cho, MD

Ajou University School of Medicine

Information Provided By

GL Pharm Tech Corporation

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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