Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers

Study Overview
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Brief Summary
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A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.

Detailed Description
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After subjects have signed informed consent voluntarily, they go through screening period for within 21 days. Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period). At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period). At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

Official Title
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A Randomized, Open-label, Six-sequence, Three-period, Multiple Dosing Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject, aged 19- 50 years at screening. Body weight between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9 Exclusion Criteria: History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)] Participation in any other study within 2 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A Group<br>Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) | Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |
| Other: B Group<br>Fimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) | Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |
| Other: C Group<br>Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) | Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |
| Other: D Group<br>Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) | Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |
| Other: E Group<br>Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) | Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |
| Other: F Group<br>Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) | Drug: Fimasartan<br> <br> Drug: Atorvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC tau,ss |  | Time Frame: 0 48 hour after medication | 
| Cmax,ss |  | Time Frame: 0 48 hour after medication | 

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