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

An Open-label, Randomized, Fasting, 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
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06993181
Enrollment
48
Registered
2025-05-28
Start date
2025-06-30
Completion date
2025-07-31
Last updated
2025-06-06

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 DA-5222 single-administration and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects

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)

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

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

MeasureTime frameDescription
AUCtpre-dose~72 hours post-dosearea under the curve
Cmaxpre-dose~72 hours post-dosemaximum plasma concentration

Countries

South Korea

Contacts

Primary ContactJihyun Sung
jhsung@donga.co.kr+82-02-920-8369
Backup ContactHeechan Jung
hcjung@donga.co.kr+82-02-920-8322

Outcome results

None listed

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