Pharmacokinetics of HCP1401 and Co-administration of HCP0605, HGP1405 in Healthy Male Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers

Detailed Description
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The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605, HGP1405 in healthy male volunteers

Official Title
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A Randomized, Open-label, Oral Single Dose, Two-way Crossover Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability After Administration of HCP1401 and Co-administration of HCP0605 and HGP1405 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: HCP0605
* Drug: HGP1405
* Drug: HCP1401


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age 19 45 years Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2 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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric 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 A<br>Period 1 : HCP0605+HGP1405 Period 2 : HCP1401 | Drug: HCP0605<br> <br> Drug: HGP1405<br> <br> Drug: HCP1401<br> <br> |
| Experimental: Sequence B<br>Period 1 : HCP1401 Period 2 : HCP0605+HGP1405 | Drug: HCP0605<br> <br> Drug: HGP1405<br> <br> Drug: HCP1401<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | Area under the plasma concentration versus time curve | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose | 
| Cmax | Peak Plasma Concentration | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose | 
| Tmax |  | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose | 
| T1/2 |  | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose | 
| Cl/F |  | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose | 
| Vz/F |  | pre-dose(0h), 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 120, 144 h post-dose |