Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

Study Overview
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Brief Summary
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A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers

Official Title
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A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil Administered in Healthy Male Volunteer

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Dutasteride 0.5 mg
* Drug: Tadalafil 5 mg
* Drug: YY-201


Participation Criteria
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Eligibility Criteria
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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 Medical 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 Smoked more than 10 cigarettes a day for past 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 Positive result from Serum test Clinically significant disorders result from Electrocardiography test Not eligible due to investigator's judgments

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dutasteride&Tadalafil<br>Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose | Drug: Dutasteride 0.5 mg<br>* single dose<br>Drug: Tadalafil 5 mg<br>* single dose<br>|
| Experimental: YY-201<br>YY-201 capsule, singe dose | Drug: YY-201<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak Plasma Concentration of Dutasteride, tadalafil | Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time at which the maximum concentration of Dutasteride, Tadalafil | Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11) | 
| t1/2β | half-life | Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11) | 
| AUCinf | area under the plasma concentration versus time curve of Dutasteride, Tadalafil | Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11) | 

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