Skip to main content
OpenTrials
Completed

NCT Number: NCT05132049

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

Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bumin Hospital

Seoul, 07590, 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 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

Treatment and study plan

DA-5211

Drug

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

DA-5211-R1 + DA-5211-R2

Drug

single dose administration (DA-5211-R1 one tablet once a day + DA-5211-R2 one tablet once a day)

Primary outcomes

  1. AUCt

    Time frame: pre-dose~72 hours post-dose

    area under the curve

  2. Cmax

    Time frame: pre-dose~72 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, 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Jun 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.