Cardiovascular Diseases
Conditions
Brief summary
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions
Detailed description
A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions
Interventions
DRUGReference drug
1 Cap., single oral administration under fed condition
DRUGTest drug 1
1 Tab., single oral administration under fed condition
DRUGTest drug 2
1 Tab., single oral administration under fed condition
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult aged more than 19 at the time of screening 2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) \< 30.0kg/m² \# BMI=Weight(kg) / Height(m)² 3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination. 4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening. 5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations. 6. Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.
Exclusion criteria
1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth). 2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug. 3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening. 4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs. 5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products. 6. Those who have taken any drugs that may affect the clinical trial within 10 days. 7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products. 8. Those who is unable to consume a high-fat meal provided during the study. 9. Those who are deemed insufficient to participate in this clinical study by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Area under the concentration-time curve from time zero to time of CKD-385 |
| Cmax of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Maximum plasma concentration of CKD-385 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Terminal elimination half-life of CKD-385 |
| AUCinf of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Area under the concentration-time curve from zero up to infinity of CKD-385 |
| Vd/F of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Apparent Volume of Distribution of CKD-385 |
| CL/F of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Apparent clearance of CKD-385 |
| Tmax of CKD-385 | Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours | Time to maximum plasma concentration of CKD-385 |
Countries
South Korea
Outcome results
None listed