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To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of DA-5222 in Healthy Adult Subjects

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06993168
Enrollment
32
Registered
2025-05-28
Start date
2025-05-21
Completion date
2025-07-31
Last updated
2025-05-28

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 evaluate the effect of food on pharmacokinetics of DA-5222 in healthy adult subjects

Interventions

DRUGDA-5222

single dose administration (DA-5222 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

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