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

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Dong-A ST Co., Ltd.
Updated on 11 June 2026
Accepts healthy volunteers

Summary

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

Details
Condition Healthy Adult
Age 19years - 55years
Clinical Study IdentifierNCT07633691
SponsorDong-A ST Co., Ltd.
Last Modified on11 June 2026

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
The subjects who are pregnant or lactating
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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