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

Benign Prostatic Hyperplasia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240939
• Other study ID #: YY-201_PK
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2017
• Last updated: November 21, 2017
• Start date: March 27, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: May 2017
• Source: Yuyu Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 10, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Dutasteride 0.5 mg
single dose
• Tadalafil 5 mg
single dose
• YY-201
single dose

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuyu Pharma, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	"Peak Plasma Concentration" of Dutasteride, tadalafil	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)
Secondary	Tmax	Time at which the maximum concentration of Dutasteride, Tadalafil	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)
Secondary	t1/2ß	half-life	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)
Secondary	AUCinf	area under the plasma concentration versus time curve of Dutasteride, Tadalafil	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)