Clinical Trial Comparing Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects in Fed State

An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07046715

Enrollment

Registered

2025-07-01

Start date

2025-07-07

Completion date

2025-08-19

Last updated

2025-11-17

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

Conditions

Healthy

Brief summary

This study is to compare pharmacokinetics and safety profiles of single-administration of DA-5222 and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects in fed state

Interventions

DRUGDA-5222

single dose administration (DA-5222 one tablet once a day)

DRUGDA-5222-R1

single dose administration (DA-5222-R1 one tablet once a day)

DRUGDA-5222-R2

single dose administration (DA-5222-R2 one tablet once a day)

DRUGDA-5222-R3

single dose administration (DA-5222-R3 one tablet once a day)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

DA-5222, DA-5222-R1, DA-5222-R2, DA-5222-R3

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers * BMI between 18 and 30 kg/m2 * Body weight: Male≥50kg, Female≥45kg * Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion criteria

* Subjects with clinically significant medical history * Subjects with history of drug abuse or addicted * Subjects with allergy or drug hypersensitivity

Design outcomes

Primary

Measure	Time frame	Description
AUCt	pre-dose~48 hours post-dose	Area Under the Curve
Cmax	pre-dose~48 hours post-dose	Maximum Plasma Concentration

Countries

South Korea

Outcome results

None listed

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