A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

Detailed Description
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This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan
* Drug: Rosuvastatin
* Drug: Fimasartan + Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian male 19-55 years of age. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening. Medically healthy with no clinically significant medical history. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol. Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening. Plasma donation within 7 days prior to the first dose of study drug. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1 (ABC)<br>Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period. | Drug: Fimasartan<br> <br> Drug: Rosuvastatin<br> <br> Drug: Fimasartan + Rosuvastatin<br> <br> |
| Other: Sequence 2 (ACB)<br>Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. | Drug: Fimasartan<br> <br> Drug: Rosuvastatin<br> <br> Drug: Fimasartan + Rosuvastatin<br> <br> |
| Other: Sequence 3 (BAC)<br>Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period. | Drug: Fimasartan<br> <br> Drug: Rosuvastatin<br> <br> Drug: Fimasartan + Rosuvastatin<br> <br> |
| Other: Sequence 4 (BCA)<br>Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. | Drug: Fimasartan<br> <br> Drug: Rosuvastatin<br> <br> Drug: Fimasartan + Rosuvastatin<br> <br> |
| Other: Sequence 5 (CAB)<br>Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. | Drug: Fimasartan<br> <br> Drug: Rosuvastatin<br> <br> Drug: Fimasartan + Rosuvastatin<br> <br> |
| Other: Sequence 6 (CBA)<br>Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. | Drug: Fimasartan<br> <br> Drug: Rosuvastatin<br> <br> Drug: Fimasartan + Rosuvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve | This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method | For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period | 
| Maximum Observed Concentration | This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated. | For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period | 
| Time to Reach Maximum Observed Plasma Concentration | This Outcome is the time it takes a drug to reach Cmax | For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fimasartan