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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GL2907 XL 20mg (Oxycodone 20mg, fasted)

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

Oxycodone XL 20mg/day(20mg once a day, after high fat meal)

Oxycontin CR 10mg (Oxycodone 10mg, fasted)

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Oxycodone 20mg/day (10mg twice a day, fasted)

Interventions

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Oxycodone

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

Intervention Type DRUG

Oxycodone

Oxycodone XL 20mg/day(20mg once a day, after high fat meal)

Intervention Type DRUG

Oxycodone

Oxycodone 20mg/day (10mg twice a day, fasted)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes