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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 | Experimental | Oxycodone HCl 20mg |
|
| Oxycontine CR 10mg | Active Comparator | Oxycodone HCl 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GL2907 | Drug | once a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | Pharmacokinetic of Oxycodone | 48h |
| AUCÏ„ | Pharmacokinetic of Oxycodone | 24h |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Pharmacokinetic of Oxycodone | 48h |
| t1/2 | Pharmacokinetic of Oxycodone | 48h |
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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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| Oxycontine CR 10mg |
| Drug |
twice a day |
|
|
| Vz/f | Pharmacokinetic of Oxycodone | 48h |
| CL/F | Pharmacokinetic of Oxycodone | 48h |
| Cmin,ss | Pharmacokinetic of Oxycodone | 48h |
| Cave,ss | Pharmacokinetic of Oxycodone | 48h |
| degree og fluctuation | Pharmacokinetic of Oxycodone (Cmax,ss-Cmin,ss)/Cave,ss | 48h |
| swing | Pharmacokinetic of Oxycodone (Cmax,ss-Cmin,ss)/Cmin,ss | 48h |
| R | Pharmacokinetic of Oxycodone Accumulation index | 48h |
| 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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