Back to resultsPharmacokinetics 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
About this trial
This is an interventional basic science trial for Benign Prostatic Hyperplasia focused on measuring Dutasteride, Tadalafil
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
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
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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