Clinical trial NCT03240939: Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Benign Prostatic Hyperplasia
Keywords: Dutasteride
Tadalafil
Lead sponsor: Yuyu Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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
* 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

Primary outcomes:
measure: Cmax
timeFrame: 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 outcomes:
measure: Tmax
timeFrame: 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)
measure: t1/2β
timeFrame: 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)
measure: AUCinf
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyeong-Seok Lim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: