A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2013-08-01
• 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.

• 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

• Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

• ALT or AST > 1.25 times (Upper Normal Range)

• Total Bilirubin > 1.5 times (Upper Normal Range)

• CPK > 2 times (Upper Normal Range)

• BUN or Creatinine > Normal Range

• Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg