Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05132049

Enrollment

Registered

2021-11-23

Start date

2021-12-18

Completion date

2022-02-22

Last updated

2022-06-07

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-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers

Interventions

DRUGDA-5211

single dose administration (DA-5211 one tablet once a day)

DRUGDA-5211-R1 + DA-5211-R2

single dose administration (DA-5211-R1 one tablet once a day + DA-5211-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 allergy or drug hypersensitivity * 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-dose	maximum plasma concentration

Countries

South Korea

Outcome results

None listed

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