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Not yet recruitingNCT06993181Updated Jun 6, 2025

Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects

A Phase 1 interventional study of DA-5222 and DA-5222-R1 in Healthy, sponsored by Dong-A ST Co., Ltd.. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study is to compare pharmacokinetics and safety profiles of DA-5222 single-administration and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Subjects with clinically significant medical history
  • Subjects with history of drug abuse or addicted
  • Subjects with allergy or drug hypersensitivity
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Sequence A

    Drug: DA-5222 · Drug: DA-5222-R1 · Drug: DA-5222-R2 · Drug: DA-5222-R3

  • Experimental
    Sequence B

    Drug: DA-5222 · Drug: DA-5222-R1 · Drug: DA-5222-R2 · Drug: DA-5222-R3

Interventions

  • DrugDA-5222

    single dose administration (DA-5222 one tablet once a day)

  • DrugDA-5222-R1

    single dose administration (DA-5222-R1 one tablet once a day)

  • DrugDA-5222-R2

    single dose administration (DA-5222-R2 one tablet once a day)

  • DrugDA-5222-R3

    single dose administration (DA-5222-R3 one tablet once a day)

06

What researchers measure

Primary outcomes

  1. AUCt

    area under the curve

    Time frame: pre-dose~72 hours post-dose

  2. Cmax

    maximum plasma concentration

    Time frame: pre-dose~72 hours post-dose

07

Study locations

1 site
  • Bumin Hospital
    Seoul, South Korea 07590, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06993181
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
May 28, 2025
Start date
Jun 2025 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jun 6, 2025

Study contacts

Jihyun Sung
Contact
jhsung@donga.co.kr
+82-02-920-8369
Heechan Jung
Contact
hcjung@donga.co.kr
+82-02-920-8322

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies from this sponsor

Dong-A ST Co., Ltd.

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