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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

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ClinicalTrials.gov Identifier: NCT01779492
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Drug: GL2907 Drug: Oxycontine CR 10mg Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Cmax,ss [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  2. AUCτ [ Time Frame: 24h ]
    Pharmacokinetic of Oxycodone


Secondary Outcome Measures :
  1. Tmax [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  2. t1/2 [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  3. Vz/f [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  4. CL/F [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  5. Cmin,ss [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  6. Cave,ss [ Time Frame: 48h ]
    Pharmacokinetic of Oxycodone

  7. degree og fluctuation [ Time Frame: 48h ]

    Pharmacokinetic of Oxycodone

    (Cmax,ss-Cmin,ss)/Cave,ss


  8. swing [ Time Frame: 48h ]

    Pharmacokinetic of Oxycodone

    (Cmax,ss-Cmin,ss)/Cmin,ss


  9. R [ Time Frame: 48h ]

    Pharmacokinetic of Oxycodone

    Accumulation index




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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT01779492     History of Changes
Other Study ID Numbers: GL2907-102
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

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

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