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NCT06483243CompletedPhase 1

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.

A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State

Source: ClinicalTrials.gov · Last updated 3 Jul 2024

Brief summary (registry, in English)

This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
45 (actual)
First submitted
13 Jun 2024
Start date
Apr 2024
Primary completion date
Apr 2024
Lead sponsor
Chong Kun Dang Pharmaceutical
NCT number
NCT06483243

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 45
  • From Apr 2024 to the primary completion date, Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period 1 administration)

Other

  • Other exclusive criteria, as defined in the protocol

Who the study is looking for

  • Healthy adults aged 19 to 65 years
  • Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
  • within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
  • Other inclusion criteria, as defined in the protocol

Age in the registry: 19 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chung-Ang University Gwangmyeong Hospital
Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.