Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05739851

Enrollment

Registered

2023-02-22

Start date

2023-03-18

Completion date

2023-04-14

Last updated

2023-02-22

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

Conditions

Healthy

Brief summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01(2.5/500 mg) at fasting state.

Interventions

DRUGDA-1229_01 2.5/500mg (Before)

single dose administration (one tablet once a day)

DRUGDA-1229_01 2.5/500mg (After)

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 and 30 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	pre-dose~96 hours post-dose	area under the curve
Cmax	pre-dose~96 hours post-dose	maximum plasma concentration

Countries

South Korea

Outcome results

None listed

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