A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Study Overview
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Brief Summary
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A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Official Title
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A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: HCP1904-1
* Drug: HCP1904-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 45 years in healthy male volunteers Weight ≥ 55kg and BMI 18   30 kg/m^2 Subjects who agree to use medically accepted dual contraceptives up to 14 days 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>Period1: HCP1904-1 | Drug: HCP1904-1<br>* take it once per period<br>|
| Experimental: group2<br>Period1: HCP1904-3 | Drug: HCP1904-3<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 |
| --- | --- | --- |
| Cmax of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| AUC last of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| AUC inf of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Tmax of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| t1/2 of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| CL/F of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Vd/F of Losartan | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Cmax of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| AUC last of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| AUC inf of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Tmax of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| t1/2 of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| CL/F of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Vd/F of EXP3174 | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Cmax of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| AUC last of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| AUC inf of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Tmax of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| t1/2 of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| CL/F of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours | 
| Vd/F of Chlorthalidone | pharmacokinetic evaluation | Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour) 144hours |