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A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2

NCT ID: NCT05214690

Last Updated: 2022-01-31

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

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-13

Study Completion Date

2020-09-08

Brief Summary

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Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study

Detailed Description

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Conditions

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Osteoarthritis Rheumatoid Arthritis Back Pain Acute Upper Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

cross-over

Group Type EXPERIMENTAL

DW1809-T2

Intervention Type DRUG

pelubiprofen 25mg

DW1809-1

Intervention Type DRUG

pelubiprofen 30mg (PELUBI tab.)

Sequence B

cross-over

Group Type EXPERIMENTAL

DW1809-T2

Intervention Type DRUG

pelubiprofen 25mg

DW1809-1

Intervention Type DRUG

pelubiprofen 30mg (PELUBI tab.)

Interventions

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DW1809-T2

pelubiprofen 25mg

Intervention Type DRUG

DW1809-1

pelubiprofen 30mg (PELUBI tab.)

Intervention Type DRUG

Other Intervention Names

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Test Reference

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers who are ≥19 years old
* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria

* Clinically significant Medical History
* In the case of women, pregnant(Urine-HCG positive) or lactating women
Minimum Eligible Age

19 Years

Eligible Sex

ALL

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

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW1809-102

Identifier Type: -

Identifier Source: org_study_id