A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.

Official Title
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A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: HCP1007
* Drug: Omarco and Crestor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male aged 20 to 55 years A body mass index between 19 and 27 kg/m2 Exclusion Criteria: History of hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic or cardiovascular disease SBP < 90 or ≥ 150 mmHg, DBP < 60 or ≥90 mmHg Use of herbal medicine within 30 days, prescriptive medicine within 14 days, or over-the-counter drug within 7 days Heavy alcohol consumption (140 g/day)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Group 1<br>R1: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap in the fasting state R2: Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap on the high-fat diet T1: Single-dose of HCP1007 1g/5mg 4 cap in the fasting state T2: Single-dose of HCP1007 1g/5mg 4 cap on the high-fat diet R1 -> T2 -> R2 -> T1 | Drug: HCP1007<br> <br> Drug: Omarco and Crestor<br> <br> |
| Experimental: Group 2<br>R2 -> R1 -> T1 -> T2 | Drug: HCP1007<br> <br> Drug: Omarco and Crestor<br> <br> |
| Experimental: Group 3<br>T1 -> R2 -> T2 -> R1 | Drug: HCP1007<br> <br> Drug: Omarco and Crestor<br> <br> |
| Experimental: Group 4<br>T2 -> T1 -> R1 -> R2 | Drug: HCP1007<br> <br> Drug: Omarco and Crestor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax_adj of DHA and EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only) | 
| AUClast_adj of DHA and EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of DHA, EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet) | 
| AUClast of DHA, EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet) | 
| AUClast of DHA and EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet) | 
| tmax of DHA and EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet) | 
| t1/2 of DHA and EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet) | 
| AUCinf of DHA and EPA |  | -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCP1007, Rosuvastatin, Omega-3