Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

Study Overview
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Brief Summary
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This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.

Official Title
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A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.


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 The weight range is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9 Subjects with no history of any significant chronic disease Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration Willing to adhere to protocol requirements and sign a informed consent form Exclusion Criteria: History of clinically significant allergies including drug allergies History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease History of genetic muscular disease and family history hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100) AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range Creatinine clearance < 80mL/min Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines Serious injury, surgery and acute illness within 4 weeks prior to drug administration History of alcohol, smoking abuse alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol smoking > 10 cigarettes/day Use of any other medication, including herbal products, within the 2 weeks before dosing Participated in a previous clinical trial within 3 months prior to drug administration Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL) Subjects considered as unsuitable based on medical judgement by investigators

Ages Eligible for Study
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Minimum Age: 19 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exforge 10/160mg(amlodipine 10mg, valsartan160mg)<br>1 tablet daily for 10days | Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.<br> <br> |
| Experimental: crestor 20mg(rosuvastatin 20mg)<br>1 tablet daily for 7days | Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve) | after steady state (Administration of Investigational Product 7day or 10days) | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2 | steady state (Administration of Investigational Product) | 3 days | 

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