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

Y

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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