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A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pelubiprofen (30mg) tablet IR TID, fasting | Active Comparator |
| |
| pelubiprofen (30mg) tablet IR TID, fed | Active Comparator |
| |
| pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pelubiprofen (30mg) tablet IR | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUC of pelubiprofen(30mg) tablet IR TID | 0, 1, 2, 8, 9, 15, 16, 22 day | |
| AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD | 0, 1, 2, 8, 9, 15, 16, 22 day | |
| Cmax of pelubiprofen(30mg) tablet IR TID | 0, 1, 2, 8, 9, 15, 16, 22 day | |
| Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD | 0, 1, 2, 8, 9, 15, 16, 22 day |
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Inclusion Criteria:
Exclusion Criteria:
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| pelubiprofen SR (as a pelubiprofen 90 mg) tablet |
| Drug |
|
| ID | Term |
|---|---|
| C040375 | pelubiprofen |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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