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

An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA 2811 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04938752

Enrollment

Registered

2021-06-24

Start date

2021-07-08

Completion date

2021-08-20

Last updated

2022-06-06

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

Conditions

Healthy

Brief 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.

Interventions

DRUGDA-2811

single dose administration (one tablet once a day)

DRUGDA-2811-R

single dose administration (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 45 Years

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

* 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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

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