Benign Prostatic Hyperplasia
Conditions
Keywords
Dutasteride, Tadalafil
Brief summary
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
Interventions
Sponsors
Yuyu Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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) | Peak Plasma Concentration of Dutasteride, tadalafil |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 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) | Time at which the maximum concentration of Dutasteride, Tadalafil |
| t1/2β | 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) | half-life |
| AUCinf | 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) | area under the plasma concentration versus time curve of Dutasteride, Tadalafil |
Countries
South Korea
Outcome results
None listed