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Completed

NCT Number: NCT04304547

Clinical Study to Evauate 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, D097 and D337 in healthy adult volunteers

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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

Seongnam-si, 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-828, D097, D337, CKD-348 T1, CKD-348 T2

Drug

Subject of sequence A takes IP in the following order:

  • Each tablet of CKD-828 and D097 and D337 be taken at once
  • CKD-348 T1 1 tablet
  • CKD-348 T2 1 tabet

Other names: Sequence A

CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Drug

Subject of sequence B takes IP in the following order:

  • CKD-348 T1 1 tablet
  • CKD-348 T2 1 tablet
  • Each tablet of CKD-828 and D097 and D337 be taken at once

Other names: Sequence B

CKD-348 T2, CKD-348 T1, CKD-828, D097, D337

Drug

Subject of sequence C takes IP in the following order:

  • CKD-348 T2 1 tablet
  • Each tablet of CKD-828 and D097 and D337 be taken at once
  • CKD-348 T1 1 tablet

Other names: Sequence C

Primary outcomes

  1. Cmax

    Time frame: 0 hour ~ 144 hr

    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

Registry information

Official study title

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2020
Registry last updated
Aug 13, 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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