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

January 23, 2013 updated by: Daewon Pharmaceutical Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Number of Arms

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC of pelubiprofen(30mg) tablet IR TID Time Frame: 0, 1, 2, 8, 9, 15, 16, 22 day	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	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	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	0, 1, 2, 8, 9, 15, 16, 22 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

DW330SR-1001(Ver2.2)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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

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 Overview

Status

Conditions

Intervention / Treatment

Study Type

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on pelubiprofen (30mg) tablet IR

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Drug Interventions

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Conditions

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Drug Interventions

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