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NCT Number: NCT06616883

Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers

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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

Bumin Hospital

Seoul, South Korea, 07590

Location contact

TaeGon Hong, Ph.D

CONTACT

[email protected]

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 clinically significant medical history
  • Subjects with history of drug abuse or addicted

Treatment and study plan

DA-5221_01

Drug

single dose administration (DA-5221_01 one tablet once a day)

DA-5221_01-R1 + DA-5221_01-R2

Drug

single dose administration (DA-5221_01-R1 one tablet once a day + DA-5221_01-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-do

    maximum plasma concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Jung

CONTACT

[email protected]

+82-02-920-8361

Sung

CONTACT

[email protected]

+82-02-920-8369

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, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

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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