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

Phase 1

Not yet recruiting

• Conditions: Healthy Adult
• Interventions: Drug: DA-5223-R; Drug: DA-5223

• Registration Number: NCT07007533
• Lead Sponsor: Dong-A ST Co., Ltd.

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 available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study Start: 2025-06
• Primary Completion: 2025-06
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DA-5223-R	-
Sequence A	DA-5223	-
Sequence B	DA-5223-R	-
Sequence B	DA-5223	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHA Global Clinical Trials Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of