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This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference-Test1-Test2 | Experimental |
| |
| Reference-Test2-Test1 | Experimental |
| |
| Test1-Reference-Test2 | Experimental |
| |
| Test1-Test2-Reference | Experimental |
| |
| Test2-Reference-Test1 | Experimental |
| |
| Test2-Test1-Reference | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-386(4) F1 | Drug | 1 Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of CKD-386 | Area under the CKD-386 concentration in blood-time curve from 0 to t | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours |
| Cmax of CKD-386 | The maximum CKD-386 concentration in blood sampling time t | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours |
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Inclusion Criteria:
Healthy adults volunteers aged ≥19 years
Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg BMI = Weight(kg)/ Height(m)2
Following vital signs results at screening
Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, serology, urology etc.) and ECG etc. performed
Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content
Exclusion Criteria:
Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
Individuals who donated whole blood within the 8 weeks, or blood components within 4 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational drugs
Individuals who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
Individuals who meet the following condition with 1 month of the first administration of investigational drugs
Patients with the following diseases
Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
Those who are deemed insufficient to participate in this clinical study by investigators
Woman who are pregnant or breastfeeding
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| Name | Affiliation | Role |
|---|---|---|
| Jaewoo Kim, M.D. | Gwanak-gu, Seoul, South Korea, 08779 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H+ Yangji Hospita | Seoul | South Korea |
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|
| CKD-386(4) F2 | Drug | 1 Tablet |
|
|
| D013, D326, D337 | Drug | D013 1 Tablet, D326 1Tablet, D337 1 Tablet |
|
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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