Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers (NCT07748702) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-339 in Healthy Volunteers
South Korea76 participantsStarted 2026-08-20
Plain-language summary
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.
Who can participate
Age range
19 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
. Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)
. Subjects who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits.
. Subjects judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP.
. Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
. Subjects who had agreed to use medically appropriate contraceptive methods\* to exclude the possibility of pregnancy from the first dose of the IP to 14 days after the last dose, and not to donate sperm or ovum.
Exclusion criteria
. Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP.
. Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
. Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
. Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP.
. Patients with the following conditions
. Subjects with a history of psychiatric disorders.
. Subjects who are considered unsuitable for participation in this bioequivalence study by the Investigator (or delegated Sub-investigator) for reasons other than the inclusion and exclusion criteria listed above.