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

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

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

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