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Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05449704
Enrollment
90
Registered
2022-07-08
Start date
2022-07-08
Completion date
2022-09-07
Last updated
2022-07-08

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

Conditions

Healthy

Brief summary

Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers

Interventions

DRUGDA-5218

single dose administration (DA-5218 one tablet once a day)

DRUGDA-5218-R1 + DA-5218-R2 + DA-5218-R3

single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-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

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

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+82-2-920-8369

Outcome results

None listed

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