Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin

Study Overview
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Brief Summary
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This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers Hypothesis: YHP1604 and telmisartan/amlodipine and rosuvastatin are showing equal pharmacokinetics.

Detailed Description
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This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers. In ARM1, 30 subjects will be assigned and the subjects will be administered telmisartan/amlodipine and rosuvastatin at Day1 and YHP1604 at Day22. In ARM2, 30 subjects will be assigned and the subjects will be administered YHP1604 at Day1 and telmisartan/amlodipine and rosuvastatin at Day22.

Official Title
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A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: Temisartan/Amlodipine+Rosuvastatin
* Drug: YHP1604


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs Administration of other investigational products within 3 months prior to the first dosing Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Ages Eligible for Study
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Minimum Age: 19 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
Interventional Model Description: A randomized, open-label, single dose, crossover clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ARM1<br>In ARM1, 30 subjects will be assigned and the subjects will be administered telmisartan/amlodipine and rosuvastatin at Day1 and YHP1604 at Day22. | Drug: Temisartan/Amlodipine+Rosuvastatin<br>* All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.<br>* Other names: Twynsta Tab.+Crestor Tab.;Drug: YHP1604<br>* All subjects will receive a single oral dose of YHP1604 administered in the morning.<br>* Other names: FDC;|
| Other: ARM2<br>In ARM2, 30 subjects will be assigned and the subjects will be administered YHP1604 at Day1 and telmisartan/amlodipine and rosuvastatin at Day22. | Drug: Temisartan/Amlodipine+Rosuvastatin<br>* All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.<br>* Other names: Twynsta Tab.+Crestor Tab.;Drug: YHP1604<br>* All subjects will receive a single oral dose of YHP1604 administered in the morning.<br>* Other names: FDC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast | Cmax, AUClast | 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs |