About this trial
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Male subjects weighing at least 50 kg
Female subjects weighing at least 45 kg
Disqualifiers
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.
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.
Trial design
Crossover
Treatments tested in this trial
CKD-339
DrugQD, PO
D311, D107
DrugQD, PO
Treatment groups
Trial outcomes
Primary outcomes
AUCt of CKD-339
Area under the plasma CKD-339 concentration-time curve from 0 to t
Cmax of CKD-339
The maximum concentration of CKD-339 in plasma
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: