A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.

Study Overview
=================
Brief Summary
-----------------
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.

Official Title
-----------------
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HIP1402
* Drug: HIP1801


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 45 years in healthy male volunteers BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2 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: 45 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: Sequence 1<br>Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801 | Drug: HIP1402<br>* Tamsulosin (HanmiTams Capsule) 0.4mg<br>Drug: HIP1801<br>* Tamsulosin 0.4mg<br>|
| Experimental: Sequence 2<br>Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402 | Drug: HIP1402<br>* Tamsulosin (HanmiTams Capsule) 0.4mg<br>Drug: HIP1801<br>* Tamsulosin 0.4mg<br>|
| Experimental: Sequence 3<br>High fat diet + HIP1402, Period 2 : High fat diet + HIP1801 | Drug: HIP1402<br>* Tamsulosin (HanmiTams Capsule) 0.4mg<br>Drug: HIP1801<br>* Tamsulosin 0.4mg<br>|
| Experimental: Sequence 4<br>High fat diet + HIP1801, Period 2 : High fat diet + HIP1402 | Drug: HIP1402<br>* Tamsulosin (HanmiTams Capsule) 0.4mg<br>Drug: HIP1801<br>* Tamsulosin 0.4mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour | 
| AUClast of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour | 
| Tmax of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour | 
| t1/2 of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour | 
| CL/F of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour | 
| Vd/F of Tamsulosin | pharmacokinetic evaluation | pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour |