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

Yuyu Pharma, Inc.1 site in 1 country36 target enrollmentMarch 27, 2017

ConditionsBenign Prostatic Hyperplasia

InterventionsDutasteride 0.5 mg Tadalafil 5 mg YY-201

DrugsDutasteride 0.5 mg Tadalafil 5 mg YY-201

Overview

Phase: Phase 1
Intervention: Dutasteride 0.5 mg
Conditions: Benign Prostatic Hyperplasia
Sponsor: Yuyu Pharma, Inc.
Enrollment: 36
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 27, 2017

End Date

October 10, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Yuyu Pharma, Inc.

Responsible Party

Sponsor

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

Arms & Interventions

Dutasteride&Tadalafil

Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose

Intervention: Dutasteride 0.5 mg

Dutasteride&Tadalafil

Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose

Intervention: Tadalafil 5 mg

YY-201

YY-201 capsule, singe dose

Intervention: YY-201

Outcomes

Primary Outcomes

Cmax

Time Frame: 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 Outcomes

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))
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))
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))