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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: pelubiprofen (30mg) tablet IR; Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet

• Registration Number: NCT01776697
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pelubiprofen (30mg) tablet IR TID, fed	pelubiprofen (30mg) tablet IR	-
pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD	pelubiprofen SR (as a pelubiprofen 90 mg) tablet	-
pelubiprofen (30mg) tablet IR TID, fasting	pelubiprofen (30mg) tablet IR	-

Primary Outcome Measures

Name	Time	Method
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