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Completed

NCT Number: NCT01776697

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pelubiprofen (30mg) tablet IR

Drug

pelubiprofen SR (as a pelubiprofen 90 mg) tablet

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2013
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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