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Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR (Pelubiprofen 45 mg) in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelubiprofen IR (Pelubiprofen 30 mg) | Active Comparator |
| |
| Pelubiprofen SR (Pelubiprofen 45 mg) | Experimental |
| |
| Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition | Other |
| |
| Pelubiprofen SR (Pelubiprofen 45 mg) fed condition | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelubiprofen IR (Pelubiprofen 30mg) TID | Drug |
| ||
| Pelubiprofen SR (Pelubiprofen 45 mg) BID |
| Measure | Description | Time Frame |
|---|---|---|
| (Part1) Cmax,ss of Pelubiprofen IR (Pelubiprofen 30mg) | 0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times) | |
| (Part1) Cmax,ss of Pelubiprofen SR (Pelubiprofen 45 mg) | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times) | |
| (Part1) Dose normalized AUCÏ„,ss of Pelubiprofen IR (Pelubiprofen 30mg) | 0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times) | |
| (Part1) Dose normalized AUCÏ„,ss of Pelubiprofen SR (Pelubiprofen 45 mg) | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times) | |
| (Part2) Cmax of Pelubiprofen IR (Pelubiprofen 30mg) | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) | |
| (Part2) Cmax of Pelubiprofen SR (Pelubiprofen 45 mg) | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) | |
| (Part2) AUClast of Pelubiprofen IR (Pelubiprofen 30mg) | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| (Part2) AUClast of Pelubiprofen SR (Pelubiprofen 45 mg) | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) |
| ID | Term |
|---|---|
| C040375 | pelubiprofen |
| C494814 | BID protein, human |
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