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OpenTrials
Completed

NCT Number: NCT01568450

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

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

AJOU University Hospital

Suwon, Gyeonggido, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

Oxycodone XL 20mg(20mg once a day, fasted)

Primary outcomes

  1. Cmax

    Time frame: 48hr

    Pharmacokinetic of Oxycodone

  2. AUC(0-24h)

    Time frame: 24 hr

    Pharmacokinetic of Oxycodone

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

GL Pharm Tech Corporation

Industry

Registry information

Official study 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

Acronym: GL2907-101

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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