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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: GL2907
Drug: Oxycontine CR 10mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GL Pharm Tech Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 24
Study Start Date: April 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GL2907
Oxycodone HCl 20mg
Drug: GL2907
once a day
Other Name: Oxycodone HCl 20mg
Active Comparator: Oxycontine CR 10mg
Oxycodone HCl 10mg
Drug: Oxycontine CR 10mg
twice a day
Other Name: Oxycodone HCl 10mg

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779492

Locations
Korea, Republic of
AJOU University Hospital
Suwon, Gyeonggido, Korea, Republic of
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
Principal Investigator: Doo-Yeoun Cho, MD Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT01779492     History of Changes
Other Study ID Numbers: GL2907-102
Study First Received: January 28, 2013
Last Updated: February 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by GL Pharm Tech Corporation:
Oxycodone, controlled release formulation

Additional relevant MeSH terms:
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 17, 2014