Completed

NCT Number: NCT05214677

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

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

Completed

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Key information

Conditions

Osteoarthritis Acute Upper Respiratory Tract Infection Arthritis Arthritis, Rheumatoid Autoimmune Diseases Back Pain Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW1809

Drug

pelubiprofen 30mg

Other names: Test

DW1809-1

Drug

pelubiprofen 30mg (PELUBI tab.)

Other names: Reference

Primary outcomes

Peak Plasma Concentration (Cmax)

Time frame: up to 8 hour

Pharmacokinetics of Pelubiprofen
Area under the plasma concentration versus time curve (AUC)

Time frame: up to 8 hour

Pharmacokinetics of Pelubiprofen

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jan 31, 2022
Registry last updated: Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed