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)

GL Pharm Tech

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01568450

GL2907-101

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

GL2907 XL 20mg (Oxycodone 20mg, fasted)

Experimental group

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

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

Experimental group

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Oxycontin CR 10mg (Oxycodone 10mg, fasted)

Active Comparator group

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone