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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GL2907 XL 20mg (Oxycodone 20mg, fasted) | Experimental |
| |
| GL2907 XL 20mg (Oxycodone 20mg, after high fat meal) | Experimental |
| |
| Oxycontin CR 10mg (Oxycodone 10mg, fasted) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Oxycodone XL 20mg(20mg once a day, fasted) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetic of Oxycodone | 48hr |
| AUC(0-24h) | Pharmacokinetic of Oxycodone | 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Pharmacokinetic of Oxycodone | 48 hr |
| t1/2 | Pharmacokinetic of Oxycodone | 48 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doo-Yeoun Cho, MD | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AJOU University Hospital | Suwon | Gyeonggido | South Korea |
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| Oxycodone |
| Drug |
Oxycodone XL 20mg/day(20mg once a day, after high fat meal) |
|
| Oxycodone | Drug | Oxycodone 20mg/day (10mg twice a day, fasted) |
|
| Vz/F | Pharmacokinetic of Oxycodone | 48 hr |
| CL/F | Pharmacokinetic of Oxycodone | 48 hr |
| Safety Monitoring | Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test | 27 days |
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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