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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis; Back Pain; Osteoarthritis; Acute Upper Respiratory Tract Infection
• Interventions: Drug: DW1809-T2; Drug: DW1809-1

• Registration Number: NCT05214690
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-13
• Primary Completion: 2020-09-08
• Study Completion: 2020-09-08
• Study First Submitted: 2021-12-12
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-28
• Last Update Submitted: 2022-01-28
• Study First Posted: 2022-01-31
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DW1809-T2	cross-over
Sequence A	DW1809-1	cross-over
Sequence B	DW1809-T2	cross-over
Sequence B	DW1809-1	cross-over

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of