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Trial record 58 of 663 for:    OXYCODONE

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01568450
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : January 28, 2013
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.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxycodone Phase 1

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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, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Cmax [ Time Frame: 48hr ]
    Pharmacokinetic of Oxycodone

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

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

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

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

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

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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT01568450

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

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Responsible Party: GL Pharm Tech Corporation Identifier: NCT01568450     History of Changes
Other Study ID Numbers: GL2907-101
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013
Keywords provided by GL Pharm Tech Corporation:
Oxycodone, controlled release formulation
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents