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Completed

NCT Number: NCT03240939

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

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

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Key information

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dutasteride 0.5 mg

Drug

single dose

Tadalafil 5 mg

Drug

single dose

YY-201

Drug

single dose

Primary outcomes

  1. 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

  1. Tmax

    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)

    Time at which the maximum concentration of Dutasteride, Tadalafil

  2. t1/2β

    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)

    half-life

  3. AUCinf

    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)

    area under the plasma concentration versus time curve of Dutasteride, Tadalafil

Sponsors and collaborators

Lead sponsor

Yuyu Pharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2017
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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