A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.

Official Title
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A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: HCP2001
* Drug: RLD2007
* Drug: RLD2008
* Drug: RLD2102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 54 years in healthy volunteers 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug. Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial 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: 54 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>Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102 Period 2: Fasted state + HCP2001 | Drug: HCP2001<br>* Take it once per period.<br>Drug: RLD2007<br>* Take it once per period.<br>Drug: RLD2008<br>* Take it once per period.<br>Drug: RLD2102<br>* Take it once per period.<br>|
| Experimental: Sequence 2<br>Period 1: Fasted state + HCP2001 Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102 | Drug: HCP2001<br>* Take it once per period.<br>Drug: RLD2007<br>* Take it once per period.<br>Drug: RLD2008<br>* Take it once per period.<br>Drug: RLD2102<br>* Take it once per period.<br>|
| Experimental: Sequence 3<br>Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102 Period 2: High fat diet + HCP2001 | Drug: HCP2001<br>* Take it once per period.<br>Drug: RLD2007<br>* Take it once per period.<br>Drug: RLD2008<br>* Take it once per period.<br>Drug: RLD2102<br>* Take it once per period.<br>|
| Experimental: Sequence 4<br>Period 1: High fat diet + HCP2001 Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102 | Drug: HCP2001<br>* Take it once per period.<br>Drug: RLD2007<br>* Take it once per period.<br>Drug: RLD2008<br>* Take it once per period.<br>Drug: RLD2102<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 |
| --- | --- | --- |
| AUCt | Pharmacokinetic evaluation | 0 48hr | 
| Cmax | Pharmacokinetic evaluation | 0 48hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Pharmacokinetic evaluation | 0 48hr | 
| Tmax | Pharmacokinetic evaluation | 0 48hr | 
| t1/2 | Pharmacokinetic evaluation | 0 48hr | 
| CL/F | Pharmacokinetic evaluation | 0 48hr | 
| Vd/F | Pharmacokinetic evaluation | 0 48hr |