NCT07633691

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 1, 2026

Last Update Submit

June 4, 2026

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

  • AUClast

    Area under the plasma concentration-time curve from time zero to time the last quantifiable time

    0~8 hours

  • Cmax

    Peak Plasma Concentration

    0~8 hours

Study Arms (4)

Sequence A

EXPERIMENTAL
Drug: DA-5223-RDrug: DA-5223-F

Sequence B

EXPERIMENTAL
Drug: DA-5223-RDrug: DA-5223-F

Sequence C

EXPERIMENTAL
Drug: DA-5223-RDrug: DA-5223-M

Sequence D

EXPERIMENTAL
Drug: DA-5223-RDrug: DA-5223-M

Interventions

DA-5223-RDRUG

once a day

Sequence ASequence BSequence CSequence D
DA-5223-FDRUG

once a day

Sequence ASequence B
DA-5223-MDRUG

once a day

Sequence CSequence D

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bumin hospital

Gangseo-gu, Seoul, 07590, South Korea

RECRUITING

Central Study Contacts

Taegon Hong

CONTACT

82-02-2620-0251tghong@bumin.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

KR(1)