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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dutasteride 0.5 mg
Tadalafil 5 mg
YY-201
Sponsored by
Yuyu Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Benign Prostatic Hyperplasia focused on measuring Dutasteride, Tadalafil

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dutasteride&Tadalafil

YY-201

Arm Description

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

YY-201 capsule, singe dose

Outcomes

Primary Outcome Measures

Cmax
"Peak Plasma Concentration" of Dutasteride, tadalafil

Secondary Outcome Measures

Tmax
Time at which the maximum concentration of Dutasteride, Tadalafil
t1/2β
half-life
AUCinf
area under the plasma concentration versus time curve of Dutasteride, Tadalafil

Full Information

First Posted
April 24, 2017
Last Updated
November 21, 2017
Sponsor
Yuyu Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03240939
Brief Title
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuyu Pharma, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Dutasteride, Tadalafil

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dutasteride&Tadalafil
Arm Type
Active Comparator
Arm Description
Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose
Arm Title
YY-201
Arm Type
Experimental
Arm Description
YY-201 capsule, singe dose
Intervention Type
Drug
Intervention Name(s)
Dutasteride 0.5 mg
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5 mg
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
YY-201
Intervention Description
single dose
Primary Outcome Measure Information:
Title
Cmax
Description
"Peak Plasma Concentration" of Dutasteride, tadalafil
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)
Secondary Outcome Measure Information:
Title
Tmax
Description
Time at which the maximum concentration of Dutasteride, Tadalafil
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)
Title
t1/2β
Description
half-life
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)
Title
AUCinf
Description
area under the plasma concentration versus time curve of Dutasteride, Tadalafil
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong-Seok Lim, M.D.,Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

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

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