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Completed

NCT Number: NCT07297940

Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State

This clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 at fasting state.

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bumin hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • BMI between 18 and 30 kg/m2
  • Body weight: Male ≥ 50kg, Female ≥ 45kg
  • Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion criteria

  • Subjects with clinically significant medical history
  • Subjects with history of drug abuse or addicted
  • Subjects with allergy or drug hypersensitivity

Treatment and study plan

DA-1229_01

Drug

single dose administration (DA-1229 one tablet once a day)

DA-1229_01-R

Drug

single dose administration (DA-1229_01-R one tablet once a day)

Primary outcomes

  1. AUCt

    Time frame: pre-dose~72 hours post-dose

    Area Under the Curve

  2. Cmax

    Time frame: pre-dose~72 hours post-dose

    Maximum Plasma Concentration

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 in Healthy Subjects at Fasting State

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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