A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
- Registration Number
- NCT01568450
- Lead Sponsor
- GL Pharm Tech Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GL2907 XL 20mg (Oxycodone 20mg, fasted) Oxycodone - GL2907 XL 20mg (Oxycodone 20mg, after high fat meal) Oxycodone - Oxycontin CR 10mg (Oxycodone 10mg, fasted) Oxycodone -
- Primary Outcome Measures
Name Time Method Cmax 48hr Pharmacokinetic of Oxycodone
AUC(0-24h) 24 hr Pharmacokinetic of Oxycodone
- Secondary Outcome Measures
Name Time Method Tmax 48 hr Pharmacokinetic of Oxycodone
t1/2 48 hr Pharmacokinetic of Oxycodone
Vz/F 48 hr Pharmacokinetic of Oxycodone
CL/F 48 hr Pharmacokinetic of Oxycodone
Safety Monitoring 27 days Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test
Trial Locations
- Locations (1)
AJOU University Hospital
🇰🇷Suwon, Gyeonggido, Korea, Republic of
AJOU University Hospital🇰🇷Suwon, Gyeonggido, Korea, Republic of