A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.

Official Title
-----------------
A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2201 and Co-administration of RLD2205 and RLD2206 in Healthy Male Volunteers Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: HCP2201
* Drug: RLD2205
* Drug: RLD2206


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 55 years in healthy male volunteers 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight ≥55kg 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug. Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial 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: 55 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, Period 3: RLD2205 + RLD2206 Period 2, Period 4: HCP2201 | Drug: HCP2201<br>* Take 2 tablets once per period<br>Drug: RLD2205<br>* Take 2 tablets once per period<br>Drug: RLD2206<br>* Take 1 tablet once per period<br>|
| Experimental: Sequence 2<br>Period 1, Period 3: HCP2201 Period 2, Period 4: RLD2205 + RLD2206 | Drug: HCP2201<br>* Take 2 tablets once per period<br>Drug: RLD2205<br>* Take 2 tablets once per period<br>Drug: RLD2206<br>* Take 1 tablet once per period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abiraterone acetate AUCt | Pharmacokinetic evaluation | 0 72 hours | 
| Abiraterone acetate Cmax | Pharmacokinetic evaluation | 0 72 hours | 
| Prednisolone AUCt | Pharmacokinetic evaluation | 0 24 hours | 
| Prednisolone Cmax | Pharmacokinetic evaluation | 0 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Pharmacokinetic evaluation | 0 72 hours | 
| Tmax | Pharmacokinetic evaluation | 0 72 hours | 
| t1/2 | Pharmacokinetic evaluation | 0 72 hours | 
| CL/F | Pharmacokinetic evaluation | 0 72 hours | 
| Vd/F | Pharmacokinetic evaluation | 0 72 hours |