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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation
ClinicalTrials.gov Identifier:
NCT01779492
First received: January 28, 2013
Last updated: November 11, 2014
Last verified: November 2014

January 28, 2013
November 11, 2014
April 2013
June 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01779492 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
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
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: GL2907
    once a day
    Other Name: Oxycodone HCl 20mg
  • Drug: Oxycontine CR 10mg
    twice a day
    Other Name: Oxycodone HCl 10mg
  • Experimental: GL2907
    Oxycodone HCl 20mg
    Intervention: Drug: GL2907
  • Active Comparator: Oxycontine CR 10mg
    Oxycodone HCl 10mg
    Intervention: Drug: Oxycontine CR 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2013
June 2013   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01779492
GL2907-102
No
GL Pharm Tech Corporation
GL Pharm Tech Corporation
Not Provided
Principal Investigator: Doo-Yeoun Cho, MD Ajou University School of Medicine
GL Pharm Tech Corporation
November 2014

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