A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903

Study Overview
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Brief Summary
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An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HGP1910
* Drug: HGP1909
* Drug: HCP1903


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 45 years in healthy volunteers BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2 Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Subjects who judged ineligible by the investigator

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>Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903 | Drug: HGP1910<br>* Take it once per period.<br>Drug: HGP1909<br>* Take it once per period.<br>Drug: HCP1903<br>* Take it once per period.<br>|
| Experimental: Sequence 2<br>Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909 | Drug: HGP1910<br>* Take it once per period.<br>Drug: HGP1909<br>* Take it once per period.<br>Drug: HCP1903<br>* Take it once per period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| AUClast of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Cmax of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| AUClast of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| AUClast of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| AUCinf of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Tmax of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| t1/2 of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| CL/F of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Vd/F of Rosuvastatin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| AUCinf of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Tmax of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| t1/2 of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| CL/F of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Vd/F of Free Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| AUCinf of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Tmax of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| t1/2 of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| CL/F of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour | 
| Vd/F of Total Ezetimibe | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour |