Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects

Official Title
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A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rosuvastatin 20mg
* Drug: Ezetimibe 10mg
* Drug: Rosuvastatin 20mg + Ezetimibe 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age 19 45 years The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2 Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study History of relevant drug allergies or clinically significant hypersensitivity reaction.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Sequence 1<br>Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg | Drug: Rosuvastatin 20mg<br> <br> Drug: Ezetimibe 10mg<br> <br> Drug: Rosuvastatin 20mg + Ezetimibe 10mg<br> <br> |
| Experimental: Sequence 2<br>Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg | Drug: Rosuvastatin 20mg<br> <br> Drug: Ezetimibe 10mg<br> <br> Drug: Rosuvastatin 20mg + Ezetimibe 10mg<br> <br> |
| Experimental: Sequence 3<br>Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg | Drug: Rosuvastatin 20mg<br> <br> Drug: Ezetimibe 10mg<br> <br> Drug: Rosuvastatin 20mg + Ezetimibe 10mg<br> <br> |
| Experimental: Sequence 4<br>Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg | Drug: Rosuvastatin 20mg<br> <br> Drug: Ezetimibe 10mg<br> <br> Drug: Rosuvastatin 20mg + Ezetimibe 10mg<br> <br> |
| Experimental: Sequence 5<br>Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg | Drug: Rosuvastatin 20mg<br> <br> Drug: Ezetimibe 10mg<br> <br> Drug: Rosuvastatin 20mg + Ezetimibe 10mg<br> <br> |
| Experimental: Sequence 6<br>Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg | Drug: Rosuvastatin 20mg<br> <br> Drug: Ezetimibe 10mg<br> <br> Drug: Rosuvastatin 20mg + Ezetimibe 10mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosuvastatin AUCτ,ss |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 
| Rosuvastatin Cmax,ss |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 
| Ezetimibe Cmax,ss |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 
| Ezetimibe AUCτ,ss |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosuvastatin Tmax,ss |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 
| Rosuvastatin t1/2β |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 
| Ezetimibe Tmax,ss |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h | 
| Ezetimibe t1/2β |  | 1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h |