Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-357 and D578 in Healthy Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers

Detailed Description
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To healthy subjects of thirty(30), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Official Title
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A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy Volunteers

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: D578
* Drug: CKD-357


Participation Criteria
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Eligibility Criteria
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[Inclusion Criteria] A healthy adult whose age is over 19 years old when visiting for initial screening test Body mass index(BMI) between 17.5 30.5 kg/m^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)^2) A person with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, viral/bacterial test, the electrocardiogram (ECG), and etc. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs. The participants must have an ability and willingness to participate throughout the entire trials [Exclusion Criteria] A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, respiratory, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic(except subclinical seasonal allergies that is not treated at injection) disease. Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy) Who had following results after examination a. ALT or AST > twice higher than normal value Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g) Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial. Whose blood pressure < 100 or ≥140(systolic blood pressure) or < 70 or ≥ 90(diastolic blood pressure) Who had a medical history of alcohol and drug abuses. Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing durg. Who smokes more than 20 cigarettes per day within 6 months of the screening Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug. Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination. Who has a history of an extreme sensitivity of composition of the drug Who has hemorrhagic tendency(recently trauma, recently surgery, coagulation disorder, recently gastrointestinal bleeding)and are scheduled for surgery within one month Who has a potent to increase a danger of beat heart slowly like symptom of bradycardia and dyspnea Who had a medical history of hyperuricacidemia and gouty arthritis Who has a Pregnant or potentially pregnant. A person who is not determined unsuitable to participate in this test by the researchers

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>D578 Tab. 1T | Drug: D578<br>* D578 Tab.1T single oral administration under fasting condition<br>* Other names: Ticagrelor;|
| Experimental: Group B<br>CKD-357 Tab. 1T | Drug: CKD-357<br>* CKD-357 Tab.1T single oral administration under fasting condition<br>* Other names: Novel salts of Ticagrelor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Ticagrelor | Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 
| Cmax of Ticagrelor | Maximum plasma concentration of Ticagrelor | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Ticagrelor | Area under the plasma concentration of Ticagrelor versus time curve from time zero to time infinity | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 
| Tmax of Ticagrelor | Time to maximum concentration of of Ticagrelor | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 
| t1/2 of Ticagrelor | Apparent terminal half-life of Ticagrelor | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 
| CL/F of Ticagrelor | Total body clearance of Ticagrelor | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 
| Vd/F of Ticagrelor | Apparent volume of distribution of Ticagrelor | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours | 
| AUCt of AR-C124910XX | Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time of last quantifiable concentration | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| Cmax of AR-C124910XX | Maximum plasma concentration of AR-C124910XX | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| AUCinf of AR-C124910XX | Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time infinity | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| Tmax of AR-C124910XX | Time to maximum concentration of AR-C124910XX | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| t1/2 of AR-C124910XX | Apparent terminal half-life of AR-C124910XX | Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours |