Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State

March 26, 2026 updated by: Dong-A ST Co., Ltd.

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 in Healthy Subjects at Fasting State

This clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 at fasting state.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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
  • Subjects with allergy or drug hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Drug: DA-1229_01
single dose administration (DA-1229 one tablet once a day)
Drug: DA-1229_01-R
single dose administration (DA-1229_01-R one tablet once a day)
Experimental: Sequence B
Drug: DA-1229_01
single dose administration (DA-1229 one tablet once a day)
Drug: DA-1229_01-R
single dose administration (DA-1229_01-R one tablet once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: pre-dose~72 hours post-dose
Area Under the Curve
pre-dose~72 hours post-dose
Cmax
Time Frame: pre-dose~72 hours post-dose
Maximum Plasma Concentration
pre-dose~72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2025

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DA1229_01-M_Fast_BE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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