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OpenTrials
Completed

NCT Number: NCT04938752

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

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.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-2811

Drug

single dose administration (one tablet once a day)

DA-2811-R

Drug

single dose administration (one tablet once a day)

Primary outcomes

  1. AUClast

    Time frame: pre-dose~48 hours post-dose

    Area under the plasma concentration-time curve from time zero to time the last quantifiable time

  2. Cmax

    Time frame: pre-dose~48 hours post-dose

    Maximum plasma concentration

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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