drugset / Trial / NCT01870102

Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects

NCT01870102

RandomizedCrossoverOpen-label

Summary

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

Timeline

Start
Primary completion
2013-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pelubiprofen Small molecule 30 mg
Comparator Pelubiprofen Small molecule 45 mg

Indications

No indication recorded.