A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects

NCT ID: NCT07007520

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2025-11-30

Brief Summary

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This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects

Detailed Description

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Conditions

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Healthy Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Sequence A

Group Type EXPERIMENTAL

DA-5223(Fasting)

Intervention Type DRUG

once a day

DA-5223(Fed)

Intervention Type DRUG

once a day

Sequence B

Group Type EXPERIMENTAL

DA-5223(Fasting)

Intervention Type DRUG

once a day

DA-5223(Fed)

Intervention Type DRUG

once a day

Interventions

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DA-5223(Fasting)

once a day

Intervention Type DRUG

DA-5223(Fed)

once a day

Intervention Type DRUG

Eligibility Criteria

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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 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
* The subjects who are pregnant or lactating
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHA Global Clinical Trials Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Wonsuk Shin

Role: CONTACT

82-31-780-5346

Facility Contacts

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CHA Global Clinical Trials Center

Role: primary

82-031-780-3458

Other Identifiers

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DA5223_FE_I

Identifier Type: -

Identifier Source: org_study_id

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