NCT05214690

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

26 days

First QC Date

December 12, 2021

Last Update Submit

January 28, 2022

Conditions

OsteoarthritisRheumatoid ArthritisBack PainAcute Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    Pharmacokinetics of Pelubiprofen

    up to 8 hour

  • Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetics of Pelubiprofen

    up to 8 hour

Study Arms (2)

Sequence A

EXPERIMENTAL

cross-over

Drug: DW1809-T2Drug: DW1809-1

Sequence B

EXPERIMENTAL

cross-over

Drug: DW1809-T2Drug: DW1809-1

Interventions

DW1809-T2DRUG

pelubiprofen 25mg

Also known as: Test
Sequence ASequence B
DW1809-1DRUG

pelubiprofen 30mg (PELUBI tab.)

Also known as: Reference
Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidBack Pain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2021

First Posted

January 31, 2022

Study Start

August 13, 2020

Primary Completion

September 8, 2020

Study Completion

September 8, 2020

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

KR(1)