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

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Acute Upper Respiratory Tract Infection; Back Pain; Osteoarthritis; Rheumatoid Arthritis

Treatments: Drug: DW1809-1; Drug: DW1809

Study type: Interventional

Funder types: Industry

Identifiers

NCT05214677

DW1809-103

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Sequence A

Experimental group

Description:

cross-over

Treatment:

Drug: DW1809

Drug: DW1809-1

Sequence B

Experimental group

Description:

cross-over

Treatment:

Drug: DW1809

Drug: DW1809-1