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Completed

NCT Number: NCT04272502

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Completed

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 19 ≤ age ≤ 45
  • Health Volunteers
  • Subject who agreeds to participate in this clinical trial voluntarily

Exclusion criteria

  • Subject who cannot participate in a clinical trial based on the PI's judgment

Treatment and study plan

CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Drug

Each arm has a different order for taking IP

Primary outcomes

  1. Cmax

    Time frame: 0 hour ~ 144 hour

    Maximum plasma concentration of the drug

  2. AUCt

    Time frame: 0 hour ~ 144 hour

    Area under the concentration-time curve from time zero to time

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

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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