CompletedNCT04938752Updated Jun 6, 2022

Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)

A Phase 1 interventional study of DA-2811 and DA-2811-R in Healthy, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.

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

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 19 Years to 45 Years
Sex: All

Study summary

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.

Conditions studied

Healthy

In context

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

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

Who can participate

Ages eligible: 19 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male and/or female subjects
BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress

Exclusion criteria

Exclusion Criteria:

Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Sequence I
Drug: DA-2811 · Drug: DA-2811-R
Experimental
Sequence II
Drug: DA-2811 · Drug: DA-2811-R

Interventions

DrugDA-2811
single dose administration (one tablet once a day)
DrugDA-2811-R
single dose administration (one tablet once a day)

What researchers measure

Primary outcomes

AUClast
Area under the plasma concentration-time curve from time zero to time the last quantifiable time
Time frame: pre-dose~48 hours post-dose
Cmax
Maximum plasma concentration
Time frame: pre-dose~48 hours post-dose

Study locations

1 site

Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04938752
Lead sponsor: Dong-A ST Co., Ltd.
Responsible party: Sponsor
First posted: Jun 24, 2021
Start date: Jul 8, 2021
Primary completion: Aug 20, 2021
Completion: Aug 20, 2021
Last update: Jun 6, 2022

Study contacts

Chung JaeYong

principal investigator · Seoul National University Bundang Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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