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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

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ClinicalTrials.gov Identifier: NCT01776697
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : March 2012
Primary Completion Date : April 2012
Study Completion Date : April 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. AUC of pelubiprofen(30mg) tablet IR TID [ Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day ]
  2. AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD [ Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day ]
  3. Cmax of pelubiprofen(30mg) tablet IR TID [ Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day ]
  4. Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD [ Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
More Information

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01776697     History of Changes
Other Study ID Numbers: DW330SR-1001(Ver2.2)
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013