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Not yet recruiting NCT07513649

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

Phase I Interventional Healthy Adult Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DA-5230, DA-5230-R.
Who it may be relevant to
Registry conditions: Healthy Adult Participants. Basic parameters: 19 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug DA-5230
    Test drug
  • Drug DA-5230-R
    Reference drug

Primary outcome measures

  • AUCt [Time frame: pre-dose (0hour) to 72hours]
  • Cmax [Time frame: pre-dose (0hour) to 72hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07513649 · DA5230_BE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗