A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

Study Overview
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Brief Summary
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An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Official Title
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An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HCP1701
* Drug: HCP1306
* Drug: HGP0904
* Drug: HGP0608


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 agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm. 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 (Reference-Test)<br>Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701 | Drug: HCP1701<br>* Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium<br>Drug: HCP1306<br>* Ezetimibe /Rosuvastatin<br>Drug: HGP0904<br>* Amlodipine<br>Drug: HGP0608<br>* Losartan potassium<br>|
| Experimental: Sequence 2 (Test-Reference)<br>Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608 | Drug: HCP1701<br>* Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium<br>Drug: HCP1306<br>* Ezetimibe /Rosuvastatin<br>Drug: HGP0904<br>* Amlodipine<br>Drug: HGP0608<br>* Losartan potassium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Amlodipine | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours | 
| AUClast of Amlodipine | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours | 
| Cmax of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | 
| AUClast of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | 
| Cmax of Rosuvastatin | Pharmacokinetic evaluation | Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours | 
| AUClast of Rosuvastatin | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours | 
| Cmax of Free Ezetimibe | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours | 
| AUClast of Free Ezetimibe | Pharmacokinetic evaluation | Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours | 
| Cmax of EXP3174 | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | 
| AUClast of EXP3174 | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Total Ezetimibe | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours | 
| AUClast of Total Ezetimibe | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours |