Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

Study Overview
=================
Brief Summary
-----------------
A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Official Title
-----------------
A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers

Conditions
-----------------
Healthy Male Volunteers

Intervention / Treatment
-----------------
* Drug: HGP1607
* Drug: HGP1501
* Drug: HGP1607+HGP1501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.age 19 40 years 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2 3.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
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seguence 1<br>Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501 | Drug: HGP1607<br>* Take it once per period<br>Drug: HGP1501<br>* Take it once per period<br>Drug: HGP1607+HGP1501<br>* Take it once per period<br>|
| Experimental: Seguence 2<br>Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501 | Drug: HGP1607<br>* Take it once per period<br>Drug: HGP1501<br>* Take it once per period<br>Drug: HGP1607+HGP1501<br>* Take it once per period<br>|
| Experimental: Seguence 3<br>Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501 | Drug: HGP1607<br>* Take it once per period<br>Drug: HGP1501<br>* Take it once per period<br>Drug: HGP1607+HGP1501<br>* Take it once per period<br>|
| Experimental: Seguence 4<br>Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607 | Drug: HGP1607<br>* Take it once per period<br>Drug: HGP1501<br>* Take it once per period<br>Drug: HGP1607+HGP1501<br>* Take it once per period<br>|
| Experimental: Seguence 5<br>Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501 | Drug: HGP1607<br>* Take it once per period<br>Drug: HGP1501<br>* Take it once per period<br>Drug: HGP1607+HGP1501<br>* Take it once per period<br>|
| Experimental: Seguence 6<br>Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607 | Drug: HGP1607<br>* Take it once per period<br>Drug: HGP1501<br>* Take it once per period<br>Drug: HGP1607+HGP1501<br>* Take it once per period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of HGP1607 |  | 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h | 
| Cmax of HGP1607 |  | 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h | 
| baseline corrected AUClast of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h | 
| baseline corrected Cmax of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of HGP1607 |  | 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h | 
| Tmax of HGP1607 |  | 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h | 
| T1/2 of HGP1607 |  | 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h | 
| AUClast of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h | 
| Cmax of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h | 
| baseline corrected AUCinf of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h | 
| baseline corrected Tmax of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h | 
| baseline corrected T1/2 of HGP1501 |  | 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h |