Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5213 10mg in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05106205

Enrollment

Registered

2021-11-03

Start date

2021-12-21

Completion date

2022-01-20

Last updated

2022-06-13

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

Conditions

Healthy

Brief summary

Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects

Interventions

DRUGDA-5213 10mg

single dose administration (one tablet once a day)

DRUGDA-5213-R 10mg

single dose administration (one tablet once a day)

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 18.0 and 30.0 kg/m2 * Body weight : Male≥50kg, Female≥45kg

Exclusion criteria

* Allergy or Drug hypersensitivity * Clinically significant Medical History

Design outcomes

Primary

Measure	Time frame	Description
AUCt	[Time Frame: pre-dose~48 hours post-dose]	area under the curve
Cmax	[Time Frame: pre-dose~48 hours post-dose]	maximum plasma concentration

Countries

South Korea

Outcome results

None listed

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