Healthy
Conditions
Keywords
Oxycodone, controlled release formulation
Brief summary
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.
Detailed description
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
Interventions
DRUGGL2907
once a day
DRUGOxycontine CR 10mg
twice a day
Sponsors
GL Pharm Tech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,ss | 48h | Pharmacokinetic of Oxycodone |
| AUCτ | 24h | Pharmacokinetic of Oxycodone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vz/f | 48h | Pharmacokinetic of Oxycodone |
| CL/F | 48h | Pharmacokinetic of Oxycodone |
| Cmin,ss | 48h | Pharmacokinetic of Oxycodone |
| Tmax | 48h | Pharmacokinetic of Oxycodone |
| degree og fluctuation | 48h | Pharmacokinetic of Oxycodone (Cmax,ss-Cmin,ss)/Cave,ss |
| swing | 48h | Pharmacokinetic of Oxycodone (Cmax,ss-Cmin,ss)/Cmin,ss |
| R | 48h | Pharmacokinetic of Oxycodone Accumulation index |
| Cave,ss | 48h | Pharmacokinetic of Oxycodone |
| t1/2 | 48h | Pharmacokinetic of Oxycodone |
Countries
South Korea
Outcome results
None listed