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Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects

NCT ID: NCT01870102

Last Updated: 2014-01-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR (Pelubiprofen 45 mg) in healthy male volunteers

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Detailed Description

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Conditions

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Healthy Males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Pelubiprofen IR (Pelubiprofen 30 mg)

Group Type ACTIVE_COMPARATOR

Pelubiprofen IR (Pelubiprofen 30mg) TID

Intervention Type DRUG

Pelubiprofen SR (Pelubiprofen 45 mg)

Group Type EXPERIMENTAL

Pelubiprofen SR (Pelubiprofen 45 mg) BID

Intervention Type DRUG

Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition

Group Type OTHER

Pelubiprofen SR (Pelubiprofen 45 mg) BID

Intervention Type DRUG

Pelubiprofen SR (Pelubiprofen 45 mg) fed condition

Group Type OTHER

Pelubiprofen SR (Pelubiprofen 45 mg) BID

Intervention Type DRUG

Interventions

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Pelubiprofen IR (Pelubiprofen 30mg) TID

Intervention Type DRUG

Pelubiprofen SR (Pelubiprofen 45 mg) BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy males aged 20\~40 years
* BMI valued over 19 kg/m2, below 27 kg/m2
* Subjects whose blood pressure ; systolic BP over 90mmHg below 140mmHg, diastolic BP over 60mmHg below 90mmHg, stable station pulse over 45 bpm below 100 bpm
* Subjects who agree with double protective contraception or able to certificate already sterilization operation 1 day before administration of Investigational new drugs within 14 days after completion
* Subjects who voluntarily agreed with written consent

Exclusion Criteria

* Subjects with clinically significant disease or past medical history in hepatic, renal, GI tract, respiratory, musculoskeletal, endocrine, neuropsychiatry, blood tumor and cardiovascular system
* Subjects with GI tract disease (eg. Crohn's disease, peptic ulcer etc.) or surgery (except appendectomy and herniotomy) influence on administration Investigational new drugs
* Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID anti-inflammatory agents and antibiotics) including Pelubiprofen and Food
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW330SR-1002(Ver1.1.)

Identifier Type: -

Identifier Source: org_study_id

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