NCT06204107CompletedPhase 1
A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 12 Jan 2024
Brief summary (registry, in English)
This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 17 Dec 2023
- Start date
- 21 Nov 2023
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Diseases
- Type 2 diabetes
- NCT number
- NCT06204107
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 28
- From 21 Nov 2023 to the primary completion date, 6 Dec 2023
- 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
- Participated in a clinical trial within 6 months prior to 1st IP dosing
Other illness
- History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
- History of regular alcohol consumption \> 21 units/week within 6 months at the time of screening
Lab values
- AST or ALT or total bilirubin \> 1.5 times the upper limit of normal range
Other
- Other exclusive inclusion criteria, as defined in the protocol
Who the study is looking for
- Healthy adults aged 19 to 54 years
- BMI measurement result is 18.0 kg/m2 to 30 kg/m2
- Written informed consent
- Other inclusion criteria, as defined in the protocol
Age in the registry: 19 years to 54 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.