A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

Detailed Description
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This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

Official Title
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A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: Fimasartan, Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A Healthy male aged 19-50 years Body weight is over 55kg and BMI 18   27(kg/m2). A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol. A subject who is eligible according to investigator's assessment Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease. History of gastrointestinal disease and resection Hypersensitivity to ingredient of investigational product(IP) and other medication, food. Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption. A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months. Positive results for serum examination(HIV, B and C viral test, Syphilis). Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening. Participation in any other study within 3months. History of whole blood donation within 2months and Apheresis 2 weeks.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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: A fixed dose combination group<br>A fixed dose combination of Fimasartan/Atorvastatin | Drug: Fimasartan, Atorvastatin<br> <br> |
| Active Comparator: Co-administration group<br>Co-administration of Fimasartan and Atorvastatin | Drug: Fimasartan, Atorvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin |  | 0 48 hours after medication | 
| AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin |  | 0 48 hours after medication |