Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
Phase 1
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT03240939
- Lead Sponsor
- Yuyu Pharma, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description YY-201 YY-201 YY-201 capsule, singe dose Dutasteride&Tadalafil Tadalafil 5 mg Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose Dutasteride&Tadalafil Dutasteride 0.5 mg Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of