A Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects

ConditionHealthy Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorDong-A ST Co., Ltd.

About this trial

This study will exploratively evaluate the safety, tolerability and pharmacokinetics of DA-5223 compared with DA-5223-R in healthy adult subjects

Eligibility criteria

Qualifiers

Adult male or female, 19 years to 55 years

Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2

The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate

Disqualifiers

The subjects with acute illness

The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product

The subjects hypersensitive to any of the Investigational Product components or other drug components

The subjects who have continuously consumed excessive smoking or alcohol within 1 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization

Trial design

Treatments tested in this trial

  • DA-5223-R
  • DA-5223-F
  • DA-5223-M

Treatment groups

12 Participants
are divided into 4 treatment groups

Sponsors and collaborators