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A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers (GL2907-101)

This study has been completed.
Information provided by (Responsible Party):
GL Pharm Tech Corporation Identifier:
First received: March 19, 2012
Last updated: January 25, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Drug: Oxycodone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL 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 [ Time Frame: 48hr ]
    Pharmacokinetic of Oxycodone

  • AUC(0-24h) [ Time Frame: 24 hr ]
    Pharmacokinetic of Oxycodone

Secondary Outcome Measures:
  • Tmax [ Time Frame: 48 hr ]
    Pharmacokinetic of Oxycodone

  • t1/2 [ Time Frame: 48 hr ]
    Pharmacokinetic of Oxycodone

  • Vz/F [ Time Frame: 48 hr ]
    Pharmacokinetic of Oxycodone

  • CL/F [ Time Frame: 48 hr ]
    Pharmacokinetic of Oxycodone

  • Safety Monitoring [ Time Frame: 27 days ]
    Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test

Enrollment: 24
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GL2907 XL 20mg (Oxycodone 20mg, fasted) Drug: Oxycodone
Oxycodone XL 20mg(20mg once a day, fasted)
Experimental: GL2907 XL 20mg (Oxycodone 20mg, after high fat meal) Drug: Oxycodone
Oxycodone XL 20mg/day(20mg once a day, after high fat meal)
Active Comparator: Oxycontin CR 10mg (Oxycodone 10mg, fasted) Drug: Oxycodone
Oxycodone 20mg/day (10mg twice a day, fasted)


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 20~45 years old, Healthy Adult Male Subject
  • ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

  • ALT or AST > 1.25(Upper Normal Range)
  • Total Bilirubin > 1.5 (Upper Normal Range)
  • BUN or Creatinine > Normal Range
  • Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg
  Contacts and Locations
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Please refer to this study by its identifier: NCT01568450

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

Responsible Party: GL Pharm Tech Corporation Identifier: NCT01568450     History of Changes
Other Study ID Numbers: GL2907-101
Study First Received: March 19, 2012
Last Updated: January 25, 2013

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

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 23, 2017