Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 in Healthy Subjects at Fasting State

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07297940

Enrollment

Registered

2025-12-22

Start date

2025-12-14

Completion date

2026-01-31

Last updated

2026-03-31

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

Conditions

Healthy

Brief summary

This clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 at fasting state.

Interventions

DRUGDA-1229_01

single dose administration (DA-1229 one tablet once a day)

DRUGDA-1229_01-R

single dose administration (DA-1229\_01-R 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 * 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

Measure	Time frame	Description
AUCt	pre-dose~72 hours post-dose	Area Under the Curve
Cmax	pre-dose~72 hours post-dose	Maximum Plasma Concentration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026