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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776697

Enrollment

Unknown

Registered

2013-01-28

Start date

2012-03-31

Completion date

2012-04-30

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGpelubiprofen (30mg) tablet IR

DRUGpelubiprofen SR (as a pelubiprofen 90 mg) tablet

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026