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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01776697
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: pelubiprofen (30mg) tablet IR
Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet
Phase 1

Study Type: Interventional
Official Title: 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

Further study details as provided by Daewon Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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 ]

Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pelubiprofen (30mg) tablet IR TID, fasting Drug: pelubiprofen (30mg) tablet IR
Active Comparator: pelubiprofen (30mg) tablet IR TID, fed Drug: pelubiprofen (30mg) tablet IR
Experimental: pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD Drug: pelubiprofen SR (as a pelubiprofen 90 mg) tablet

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01776697     History of Changes
Other Study ID Numbers: DW330SR-1001(Ver2.2)
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on August 28, 2014