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CompletedNCT05214677Updated Jan 31, 2022

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

A Phase 1 interventional study of DW1809 and DW1809-1 in Osteoarthritis, Rheumatoid Arthritis and Back Pain, sponsored by Daewon Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Aug 2020, registered Dec 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Back Pain
  • Acute Upper Respiratory Tract Infection
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 38 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Clinically significant Medical History
  • In the case of women, pregnant(Urine-HCG positive) or lactating women
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Sequence A

    cross-over

    Drug: DW1809 · Drug: DW1809-1

  • Experimental
    Sequence B

    cross-over

    Drug: DW1809 · Drug: DW1809-1

Interventions

  • DrugDW1809

    pelubiprofen 30mg

    Also known as: Test

  • DrugDW1809-1

    pelubiprofen 30mg (PELUBI tab.)

    Also known as: Reference

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Pharmacokinetics of Pelubiprofen

    Time frame: up to 8 hour

  2. Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetics of Pelubiprofen

    Time frame: up to 8 hour

07

Study locations

1 site
  • Chungbuk National University Hospital
    Cheongju-si, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05214677
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 31, 2022
Start date
Aug 15, 2020
Primary completion
Sep 7, 2020
Completion
Sep 7, 2020
Last update
Jan 31, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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