Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

Study Overview
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Brief Summary
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Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.

Official Title
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An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Candesartan32mg
* Drug: Amlodipine10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male, Age 20 to 45 Subject must be willing and able to provide written informed consent to the study. Exclusion Criteria: History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system. History of any significant gastrointestinal system and surgery of gastrointestinal. History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic. Over 10 tobaccos a day. Other condition which in the opinion of the investigator preclude endrollment into the study.

Ages Eligible for Study
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Minimum Age: 20 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: PartA: Candesartan, Candesartan + Amolodipine<br>Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally | Drug: Candesartan32mg<br> <br> Drug: Amlodipine10mg<br> <br> |
| Active Comparator: PartB: Amlodipine, Amlodipine+Candesartan<br>Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally | Drug: Candesartan32mg<br> <br> Drug: Amlodipine10mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A : AUC, Cmax of Candesartan |  | Over a 24-hour sampling period | 
| Par B : AUC, Cmax of Amlodipine |  | Over a 24-hour sampling period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PartA: Cmin, tmax, CL/F of Candesartan |  | Over a 24-hour sampling period | 
| PartB: Cmin, tmax, CL/F of Amlodipine |  | Over a 24-hour sampling period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety, Male