Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

Yuyu Pharma

Status and phase: Completed; Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Dutasteride 0.5 mg; Drug: YY-201; Drug: Tadalafil 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03240939

YY-201_PK

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Dutasteride&Tadalafil

Active Comparator group

Description:

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

Treatment:

Drug: Tadalafil 5 mg

Drug: Dutasteride 0.5 mg

YY-201

Experimental group

Description:

YY-201 capsule, singe dose

Treatment:

Drug: YY-201