A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy male volunteers.

Conditions
-----------------
Benign Prostate Hyperplasia

Intervention / Treatment
-----------------
* Drug: Tadalafil
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 to 45 years BMI score 19 kg/m2 to 28 kg/m2 SBP < 140 mmHg and ≤ 90 mmHg or DBP < 90 mmHg and ≥ 50 mmHg Eligible according to the laboratory results of hematology, blood chemistry and urinalysis Voluntarily signed the informed consent form Exclusion Criteria: Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months History of hypersensitivity History of Cardiovascular disease History of degenerative Retina disease Lactose intolerance History of vision loss Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system Donated whole blood (transfusion, apheresis etc..) within 60 days Participated and administered the investigational products in other clinical trial within 90 days Taking drugs which may affect Clinical trial within 30 days Excessive alcohol consumption (> 3 units/week, 1 unit) Taking food which may affect Clinical trial within 7 days Positive result from Urinary test, Serum test Not eligible due to other reasons including laboratory results Clinically significant disorders result from Electrocardiography test Not eligible due to investigator's judgments

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dutasteride, Tadalafil<br> | Drug: Tadalafil<br> <br> Drug: Dutasteride<br> <br> |
| Experimental: Tadalafil, Dutasteride<br> | Drug: Tadalafil<br> <br> Drug: Dutasteride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve(AUC) of Dutasteride |  | 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours | 
| Area Under the Curve(AUC) of Tadalafil, Dutasteride |  | 0,24,72,96,96.5,97,97.5,98,99,100,102,104,106,108,120,120.5,121,121.5,122,122.5,123,123.5,124,125,126,128,132,144,152,168,192,216,264,312,360 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dutasteride, Tadalafil