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NCT05214690 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05214690
Other study ID # DW1809-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 13, 2020
Est. completion date September 8, 2020

Study information
Verified date January 2022
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date September 8, 2020
Est. primary completion date September 8, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DW1809-T2
pelubiprofen 25mg
• DW1809-1
pelubiprofen 30mg (PELUBI tab.)

Locations
Country Name City State
Korea, Republic of Chungbuk National University Hospital Cheongju-si

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

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