A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.

Detailed Description
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An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects

Official Title
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An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects

Conditions
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Alzheimer's Disease (AD)

Intervention / Treatment
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* Drug: CKD-355A (D797/Memantine HCl 20mg)
* Drug: CKD-355B (D797/Memantine HCl 20mg)
* Drug: D797
* Drug: D324 (Memantine HCl 10mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult older than 19 years and less than 55 years at the time of screening BMI 18.5 29.9 kg/m2 and body weight more than 50kg Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men Subjects who sign on an informed consent form willingly Exclusion Criteria: Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease. Subjects who have acute disease within 28 days prior to the first administration Subjects who have history that may affect the ADME Subjects who have clinically significant chronic disease Women who are nursing, pregnant or positive on pregnancy test Subjects who have clinically significant allergic diseases Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Subjects who are known to be hypersensitive to the drug or its components Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody) Subjects with creatinine clearance <60 ml / min Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration Subjects who can not eat standard meals provided by the institution. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day) Subjects who participate in the other clinical trial within 90 days prior to the first administration Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day) Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial Subjects who is determined unsuitable to participate in this clinical trial by the investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-355A<br> | Drug: CKD-355A (D797/Memantine HCl 20mg)<br>* once a day<br>|
| Experimental: CKD-355B<br> | Drug: CKD-355B (D797/Memantine HCl 20mg)<br>* once a day<br>|
| Active Comparator: D797, D324<br> | Drug: D797<br>* once a day<br>Drug: D324 (Memantine HCl 10mg)<br>* twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of D324 | Max Concentration of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| AUCt of D324 | Area under the curve of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| Cmax of D797 | Max Concentration of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| AUCt of D797 | Area under the curve of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmin of D324 | Min Concentration of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| Cmin of D797 | Min Concentration of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| Tmax of D324 | Time of Max concentration of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| Tmax of D797 | Time of Max concentration of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| t½ of D324 | Half-life time of D324 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 
| t½ of D797 | Half-life time of D797 | 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, CKD-355