Status:
COMPLETED
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
Lead Sponsor:
Yuyu Pharma, Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
19-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03240939
Start Date
March 27 2017
End Date
October 10 2017
Last Update
November 24 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505