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OpenTrials
Completed

NCT Number: NCT05106205

Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Central Hospital

Siheung-si, Gyeonggi-do, 15079, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Volunteers
  • BMI between 18.0 and 30.0 kg/m2
  • Body weight : Male≥50kg, Female≥45kg

Exclusion criteria

  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History

Treatment and study plan

DA-5213 10mg

Drug

single dose administration (one tablet once a day)

DA-5213-R 10mg

Drug

single dose administration (one tablet once a day)

Primary outcomes

  1. AUCt

    Time frame: [Time Frame: pre-dose~48 hours post-dose]

    area under the curve

  2. Cmax

    Time frame: [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 and Safety of DA-5213 10mg in Healthy Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Jun 13, 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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