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

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

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Key information

Conditions

Healthy Adult Participants

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-5230

Drug

Test drug

DA-5230-R

Drug

Reference drug

Primary outcomes

AUCt

Time frame: pre-dose (0hour) to 72hours

Area under the plasma concentration-time curve during dosing interval (AUCt)
Cmax

Time frame: pre-dose (0hour) to 72hours

Maximum concentration of drug in plasma

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 7, 2026
Registry last updated: Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting