Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

Study Overview
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Brief Summary
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An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Detailed Description
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After subjects have signed informed consent voluntarily, they go through screening period for within 28 days. As period I, subjects of Cohort1 take fimasartan and Amlodipine for 10 days and subjects of Cohort2 take rosuvastatin for 6 days. And then, as period II, subjects of both Cohorts take fimasartan, Amlodipine and rosuvastatin in Cohort1 case for 6 days and in Cohort2 case for 10 10days. For Fimasartan, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24hour after medication(32 times in total). For Amlodipine, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24hour after medication(30 times in total). For Rosuvastatin and N-desmethyl rosuvastatin, subjects of Cohort2 have blood sampling 4th, 5th, 14th, 15th day before medication, 6th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24hour after medication(28 times in total).

Official Title
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An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

Conditions
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Hypertension

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


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 within ± 20% 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 Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.25 x the upper limit of normal 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 3 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: Cohort1<br>Treatment AB → ABC Treatment A+B (10days) → Treatment A+B+C (6days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin | Drug: Fimasartan<br> <br> Drug: Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |
| Other: Cohort2<br>Treatment C → ABC Treatment C (6days) → Treatment A+B+C (10days) Treatment A: Fimasartan Treatment B: Amlodipine Treatment C: Rosuvastatin | Drug: Fimasartan<br> <br> Drug: Amlodipine<br> <br> Drug: Rosuvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss | When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin | Time Frame: 0 24 hour after medication | 
| AUC tau,ss | When 1 cohort, it's a measure on Fimasartan and Amlodipine. and when another cohort, it's a measure on Rosuvastatin | Time Frame: 0 24 hour after medication | 

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