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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.
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation
ClinicalTrials.gov Identifier:
NCT01568450
First received: March 19, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Healthy
 Drug: Oxycodone
 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, 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:

U.S. FDA Resources

Further study details as provided by GL Pharm Tech Corporation:

Primary Outcome Measures:
  • Cmax [ Time Frame: 48hr ] [ Designated as safety issue: No ]
    Pharmacokinetic of Oxycodone

  • AUC(0-24h) [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
    Pharmacokinetic of Oxycodone


Secondary Outcome Measures:
  • Tmax [ Time Frame: 48 hr ] [ Designated as safety issue: No ]
    Pharmacokinetic of Oxycodone

  • t1/2 [ Time Frame: 48 hr ] [ Designated as safety issue: No ]
    Pharmacokinetic of Oxycodone

  • Vz/F [ Time Frame: 48 hr ] [ Designated as safety issue: No ]
    Pharmacokinetic of Oxycodone

  • CL/F [ Time Frame: 48 hr ] [ Designated as safety issue: No ]
    Pharmacokinetic of Oxycodone

  • Safety Monitoring [ Time Frame: 27 days ] [ Designated as safety issue: Yes ]
    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)

  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
  • ≥ 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568450

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: NCT01568450     History of Changes
Other Study ID Numbers: GL2907-101
Study First Received: March 19, 2012
Last Updated: January 25, 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 May 23, 2013