Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg

Study Overview
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Brief Summary
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Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.

Official Title
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An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: candesartan cilexetil 32mg, amlodipine 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers in the age between 20 and 55 years old(inclusive). Body weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%. Subjects without a hereditary problems or chronic desease. Subjects whose clinical laboratory test values are inside the accepted normal range. Understand the requirements of the study and voluntarily consent to participate in the study. Exclusion Criteria: Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines. Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg. Subject with symptoms of acute disease within 14days prior to study medication dosing. Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics). Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Serum creatinine > 1.2mg/dL. smoking > 10 cigarettes/day. alcohol > 210g/week. Positive test results for drug test in urin or subject with history of substance abuse. Participation in any clinical investigation within 2 months prior to study medication dosing. Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing. Subjects considered as unsuitable based on medical judgement by investigators.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: candesartan<br>Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd | Drug: candesartan cilexetil 32mg, amlodipine 10mg<br>* Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.<br>* Other names: atacand 32mg, norvasc 10mg;|
| Experimental: amlodipine<br>Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd | Drug: candesartan cilexetil 32mg, amlodipine 10mg<br>* Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.<br>* Other names: atacand 32mg, norvasc 10mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Cmax |  | 7days, 10days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmin, tmax, CL/F |  | 7days, 10days |