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

NCT07007533 | Completed Phase 1

• 1 other identifier: DA5223_LSS_I
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence A

EXPERIMENTAL

Drug: DA-5223-R; Drug: DA-5223

Sequence B

EXPERIMENTAL

Drug: DA-5223-R; Drug: DA-5223

Interventions

DA-5223-R DRUG

once a day

Sequence A; Sequence B

DA-5223 DRUG

once a day

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
• The subjects who are pregnant or lactating

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

CHA Global Clinical Trials Center

Seongnam-si, Gyeonggi-do, 13520, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: July 4, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)