Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers

Study Overview
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Brief Summary
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To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers

Detailed Description
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The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics and Safety After Administration of HCP1105 Alone and Co-administration of HGP0918 and HGP0816 in Healthy Adult Subjects

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Drug: HCP1105
* Drug: HCP0918
* Drug: HCP0816


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Healthy male volunteers, aged 19 to 55 years. The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2 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 Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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>T → R T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab | Drug: HCP1105<br> <br> Drug: HCP0918<br> <br> Drug: HCP0816<br> <br> |
| Experimental: Sequence 2<br>R → T T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab | Drug: HCP1105<br> <br> Drug: HCP0918<br> <br> Drug: HCP0816<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline-corrected Cmax of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| baseline-corrected AUCt of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| Cmax of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| AUCt of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| AUCt of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| Tmax of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| t1/2β of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| baseline-corrected partial AUC12/24/48 of DHA total lipid & EPA total lipid |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| AUC∞ of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| Tmax of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| t1/2β of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| CL/F of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| Vdz/F of Rosuvastatin |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |