Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.

Official Title
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A Randomized, Open-label, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330(Fixed-dose Combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers(B)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Candesartan 8mg
* Drug: Amlodipine 5mg
* Drug: CKD-330 8/5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer in the age of 19-45 Body weight ≥ 55 kg and in the range of calculated IBW ±20% Subject without a hereditary problems, chronic disease and morbid symptom Suitable clinical laboratory test values Subject who sign on an informed consent form willingly Exclusion Criteria: Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system Gastrointestinal disease or gastrointestinal surgery History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs Galactose intolerance Sitting systolic blood pressure ≥ 140 mmHg or< 90 mmHg, sitting diastolic blood pressure ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 beats per minute Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range Serum Creatinine > upper limit of normal range Drug abuse Subject treated metabolizing enzyme inducers or inhibitors within 1 month Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week Subject treated Investigational product(include Bioequivalence test) within 3 months Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month Continuously taking Alcohol > 21 units/week Cigarette > 10 cigarettes/day Subjects with planning of dental treatment or any surgery Another clinical condition in judgement of investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Candesartan and Amlodipine<br>Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day | Drug: Candesartan 8mg<br>* PO, 1day or 22day<br>Drug: Amlodipine 5mg<br>* PO, 1day or 22day<br>|
| Experimental: CKD-330<br>CKD-330 8/5mg, PO, 1day or 22day | Drug: CKD-330 8/5mg<br>* PO, 1day or 22day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax(Maximum Plasma Concentration) of Candesartan |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | 
| AUCt(Area Under the Plasma Concentration-time curve) of Candesartan |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | 
| Cmax(Maximum Plasma Concentration) of Amlodipine |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | 
| AUCt(Area Under the Plasma Concentration-time curve) of Amlodipine |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | 
| tmax(Time to reach the maximum concentration) of Candesartan |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | 
| t1/2β(Time for C max to drop in half) of Candesartan |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | 
| CL/F(Clearance/Bioavailability) of Candesartan |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr | 
| AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Amlodipine |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | 
| tmax(Time to reach the maximum concentration) of Amlodipine |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | 
| t1/2β(Time for C max to drop in half) of Amlodipine |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | 
| CL/F(Clearance/Bioavailability) of Amlodipine |  | 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Healthy male volunteer, Candesartan, Amlodipine