Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.

Official Title
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A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Valsartan
* Drug: Ezetimibe/Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male Age between 19 and 50 Subjects with BMI of 18 27 kg/m2 with a weight of 55kg or more Subjects with SBP of 90 150 mmHg and DBP of 60 150 mmHg Signed informed consent Exclusion Criteria: Presence of medical history or a concurrent disease Has a history of hypersensitivity to IP ingredients

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: Sequence A<br>Ezetimibe/Rosuvastatin -> Valsartan -> Valsartan and Ezetimibe/Rosuvastatin | Drug: Valsartan<br>* Valsartan P.O<br>* Other names: Diovan;Drug: Ezetimibe/Rosuvastatin<br>* Ezetimibe/Rosuvastatin P.O<br>* Other names: Rosuzet;|
| Experimental: Sequence B<br>Valsartan -> Valsartan and Ezetimibe/Rosuvastatin-> Ezetimibe/Rosuvastatin | Drug: Valsartan<br>* Valsartan P.O<br>* Other names: Diovan;Drug: Ezetimibe/Rosuvastatin<br>* Ezetimibe/Rosuvastatin P.O<br>* Other names: Rosuzet;|
| Experimental: Sequence C<br>Valsartan and Ezetimibe/Rosuvastatin -> Ezetimibe/Rosuvastatin -> Valsartan | Drug: Valsartan<br>* Valsartan P.O<br>* Other names: Diovan;Drug: Ezetimibe/Rosuvastatin<br>* Ezetimibe/Rosuvastatin P.O<br>* Other names: Rosuzet;|
| Experimental: Sequence D<br>Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin-> Valsartan | Drug: Valsartan<br>* Valsartan P.O<br>* Other names: Diovan;Drug: Ezetimibe/Rosuvastatin<br>* Ezetimibe/Rosuvastatin P.O<br>* Other names: Rosuzet;|
| Experimental: Sequence E<br>Valsartan -> Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin | Drug: Valsartan<br>* Valsartan P.O<br>* Other names: Diovan;Drug: Ezetimibe/Rosuvastatin<br>* Ezetimibe/Rosuvastatin P.O<br>* Other names: Rosuzet;|
| Experimental: Sequence F<br>Valsartan and Ezetimibe/Rosuvastatin -> Valsartan -> Ezetimibe/Rosuvastatin | Drug: Valsartan<br>* Valsartan P.O<br>* Other names: Diovan;Drug: Ezetimibe/Rosuvastatin<br>* Ezetimibe/Rosuvastatin P.O<br>* Other names: Rosuzet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCT,ss |  | Day 1 Day 8 | 
| Cmax,ss |  | Day 1  Day 8 |