A Study to Evaluate the Bioequivalence of DA-5230 Compared to DA-5230-R

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of DA-5230 With DA-5230-R in Healthy Adult Volunteers

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07513649

Enrollment

Registered

2026-04-07

Start date

2026-04-01

Completion date

2026-05-01

Last updated

2026-04-07

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

Conditions

Healthy Adult Participants

Brief summary

A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R

Detailed description

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of DA-5230 With DA-5230-R in Healthy Adult Volunteers

Interventions

DRUGDA-5230

Test drug

DRUGDA-5230-R

Reference drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy participants aged 19 to 55 years at the time of screening visit * Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Exclusion criteria

* Participants who have received an investigational product in another clinical trial or a bioequivalence study within 6 months prior to the first dosing * Participants deemed unsuitable for participation in this clinical trial by the investigator

Design outcomes

Primary

Measure	Time frame	Description
AUCt	pre-dose (0hour) to 72hours	Area under the plasma concentration-time curve during dosing interval (AUCt)
Cmax	pre-dose (0hour) to 72hours	Maximum concentration of drug in plasma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026