A Study to Compare and Evaluate the Safety, Tolerability... | NCT07007533

Studies
A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects

NCT07007533

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Aug 19, 2025Actual

Enrollment

38Actual

Phase

Phase 1

Conditions

Healthy Adult

Interventions

DA-5223-R
DA-5223

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2025Actual

Primary Completion Date

Jul 17, 2025Actual

Completion Date

Jul 17, 2025Actual

First Submitted Date

May 28, 2025

First Submission Date that Met QC Criteria

May 28, 2025

First Posted Date

Jun 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2025

Last Update Posted Date

Aug 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will compare and evaluate the safety, tolerability and pharmacokinetics between DA-5223 and DA-5223-R in healthy adult subjects

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A	Experimental		Drug: DA-5223-R Drug: DA-5223
Sequence B	Experimental		Drug: DA-5223-R Drug: DA-5223

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5223-R	Drug	once a day	Sequence A Sequence B
DA-5223

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC0-24h	Area under the plasma concentration-time curve over the time interval from 0 to 24h	0~12 hours
Cmax	Peak Plasma Concentration	0~12 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHA Global Clinical Trials Center		Seongnam-si	Gyeonggi-do	13520	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided