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

An Open-label, Randomized, Single-dose, Crossover Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07007533

Enrollment

Registered

2025-06-06

Start date

2025-07-04

Completion date

2025-07-17

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Brief summary

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

Interventions

DRUGDA-5223-R

once a day

DRUGDA-5223

once a day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026