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Not yet recruiting NCT06616883

Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

Phase I Interventional Healthy

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-5221_01, DA-5221_01-R1 + DA-5221_01-R2.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 19 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
South Korea
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, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers

Overview

Pharmacokinetics and Safety Profiles After Administration of DA-5221\_01 and Co-administration of 5221\_01-R1 and DA-5221\_01-R2 in Healthy Adult Volunteers

Interventions

  • Drug DA-5221_01
    single dose administration (DA-5221\_01 one tablet once a day)
  • Drug DA-5221_01-R1 + DA-5221_01-R2
    single dose administration (DA-5221\_01-R1 one tablet once a day + DA-5221\_01-R2 one tablet once a day)

Primary outcome measures

  • AUCt [Time frame: pre-dose~72 hours post-dose]
  • Cmax [Time frame: pre-dose~72 hours post-do]

Eligibility criteria

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

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

South Korea · 1 center
  • Bumin Hospital — Seoul

Identifiers

NCT: NCT06616883 · DA5221_01_BE_I

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗