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Clinical Trial of Comparing DA-2902 and DA-2902-R in Healthy Adult Subjects

An Open-Label, Randomized, Single Oral Dose, Two-Sequence, Two-Period, CrossovSer Bioequivalence Study of "DA-2902" and "DA-2902-R" in Healthy Adults Under Fed Conditions

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07239453
Enrollment
40
Registered
2025-11-20
Start date
2025-11-07
Completion date
2025-12-06
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Disorder

Brief summary

This study is to compare pharmacokinetics and safety profiles of DA-2902 and DA-2902-R in healthy adult subjects

Interventions

DRUGDA-2902

single dose administration (DA-2902 one tablet once a day)

DRUGDA-2902-R

single dose administration (DA-2902-R one tablet once a day)

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 44 Years
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

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

Design outcomes

Primary

MeasureTime frame
AUCtpre-dose ~ 72 hr of pose-dose
Cmaxpre-dose ~ 72 hr of post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026