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Clinical Trials/NCT01776697
NCT01776697
Completed
Phase 1

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

Daewon Pharmaceutical Co., Ltd.0 sitesMarch 2012
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ConditionsHealthy
Interventionspelubiprofen (30mg) tablet IRpelubiprofen SR (as a pelubiprofen 90 mg) tablet
Drugspelubiprofen (30mg) tablet IRpelubiprofen SR (as a pelubiprofen 90 mg) tablet

Overview

Phase
Phase 1
Intervention
pelubiprofen (30mg) tablet IR
Conditions
Healthy
Sponsor
Daewon Pharmaceutical Co., Ltd.
Primary Endpoint
AUC of pelubiprofen(30mg) tablet IR TID
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
April 2012
Last Updated
13 years ago
Study Type
Interventional
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

pelubiprofen (30mg) tablet IR TID, fasting

Intervention: pelubiprofen (30mg) tablet IR

pelubiprofen (30mg) tablet IR TID, fed

Intervention: pelubiprofen (30mg) tablet IR

pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD

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

Outcomes

Primary Outcomes

AUC of pelubiprofen(30mg) tablet IR TID

Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day

AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD

Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day

Cmax of pelubiprofen(30mg) tablet IR TID

Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day

Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD

Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day

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