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
NCT ID: NCT01776697
Last Updated: 2013-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2012-03-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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pelubiprofen (30mg) tablet IR TID, fasting
pelubiprofen (30mg) tablet IR
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
Interventions
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pelubiprofen (30mg) tablet IR
pelubiprofen SR (as a pelubiprofen 90 mg) tablet
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
45 Years
MALE
Yes
Sponsors
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Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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DW330SR-1001(Ver2.2)
Identifier Type: -
Identifier Source: org_study_id
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