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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GL Pharm Tech Corporation
• Treatments: Oxycodone

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