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

Daewon Pharmaceutical logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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