To Evaluate the Pharmacokinetics and Safety of AD-208

Study Overview
=================
Brief Summary
-----------------
To evaluate pharmacokinetics and safety of AD-208.

Detailed Description
-----------------
The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.

Official Title
-----------------
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Drug: AD-208
* Drug: Avodart Soft Capsule 0.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Adult aged between 19 to 50 at the time of screening visit Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit No evidence of medical symptoms or signs of congenital or no chronic disease Exclusion Criteria: If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Avodart Soft Capsule 0.5mg to AD-208<br>Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab | Drug: AD-208<br>* Dutasteride 0.2mg<br>Drug: Avodart Soft Capsule 0.5mg<br>* Dutasteride 0.5mg<br>|
| Experimental: AD-208 to Avodart Soft Capsule 0.5mg<br>Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule | Drug: AD-208<br>* Dutasteride 0.2mg<br>Drug: Avodart Soft Capsule 0.5mg<br>* Dutasteride 0.5mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve in time plot (AUCt) | AUCt of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour | 
| Peak Plasma Concentration (Cmax) | Cmax of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve in time plot (AUCinf) | AUCinf of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour | 
| Time to reach Cmax(Tmax) | Tmax of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour | 
| Effective half-life(t1/2) | t1/2 of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour | 
| Clearance(CL/F) | CL/F of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour | 
| Volume of distribution(Vd/F) | Vd/F of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |