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 Volunteer

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Dutasteride 0.5 mg; Drug: Tadalafil 5 mg; Drug: YY-201

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dutasteride&Tadalafil; Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose	Drug: Dutasteride 0.5 mg; single dose; Drug: Tadalafil 5 mg; single dose
Experimental: YY-201; YY-201 capsule, singe dose	Drug: YY-201; single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
t1/2β	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)
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)

Collaborators and Investigators

• Sponsor: Yuyu Pharma, Inc.
• Investigators: Principal Investigator: Hyeong-Seok Lim, M.D.,Ph.D., Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Dutasteride; Tadalafil
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; 5-alpha Reductase Inhibitors; Tadalafil; Dutasteride
• Other Study ID Numbers: YY-201_PK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No