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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06616883

Enrollment

Registered

2024-09-27

Start date

2024-09-30

Completion date

2024-11-18

Last updated

2024-09-27

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

Conditions

Healthy

Brief summary

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

DRUGDA-5221_01

single dose administration (DA-5221\_01 one tablet once a day)

DRUGDA-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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
AUCt	pre-dose~72 hours post-dose	area under the curve
Cmax	pre-dose~72 hours post-do	maximum plasma concentration

Countries

South Korea

Contacts

Primary ContactSung

jhsung@donga.co.kr+82-02-920-8369

Backup ContactJung

jungjy@donga.co.kr+82-02-920-8361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026