Phase 1 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

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: pelubiprofen (30mg) tablet IR; Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01776697

DW330SR-1001(Ver2.2)

Details and patient eligibility

About

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.

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult Healthy males aged 20~45 years
2. weight over 45 kg, ideal body weight ±20%[Ideal weight] = [Height(cm)-100] X 0.9
3. Subjects who voluntarily agreed with written consent

Exclusion criteria

1. Patients with acute disorder within 28 days before clinical trial drugs administration
2. History of disorders(inflammatory GI tract disease, stomach ulcer, gastrectomy, liver disease) which can affect ADME of drugs
3. Patients with active GI tract, cardiovascular, respiratory, renal, endocrinal, haematological, central nerval, psychiatric disease or malignant tumor

Trial design

0 participants in 3 patient groups

pelubiprofen (30mg) tablet IR TID, fasting

Active Comparator group

Treatment:

Drug: pelubiprofen (30mg) tablet IR

pelubiprofen (30mg) tablet IR TID, fed

Active Comparator group

Treatment:

Drug: pelubiprofen (30mg) tablet IR

pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD

Experimental group

Treatment:

Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet