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

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05214690

Enrollment

Registered

2022-01-31

Start date

2020-08-13

Completion date

2020-09-08

Last updated

2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Upper Respiratory Tract Infection, Back Pain, Osteoarthritis, Rheumatoid Arthritis

Brief summary

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

Interventions

DRUGDW1809-T2

pelubiprofen 25mg

DRUGDW1809-1

pelubiprofen 30mg (PELUBI tab.)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax)	up to 8 hour	Pharmacokinetics of Pelubiprofen
Area under the plasma concentration versus time curve (AUC)	up to 8 hour	Pharmacokinetics of Pelubiprofen

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026