Back to resultsA Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
Primary Purpose
Benign Prostate Hyperplasia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tadalafil
Dutasteride
Sponsored by
About this trial
This is an interventional prevention trial for Benign Prostate 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
- 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
- Excessive alcohol consumption (> 3 units/week, 1 unit)
- Taking food which may affect Clinical trial within 7 days
- Positive result from Urinary test, Serum test
- Not eligible due to other reasons including laboratory results
- Clinically significant disorders result from Electrocardiography test
- Not eligible due to investigator's judgments
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dutasteride, Tadalafil
Tadalafil, Dutasteride
Arm Description
Outcomes
Primary Outcome Measures
Area Under the Curve(AUC) of Dutasteride
Area Under the Curve(AUC) of Tadalafil, Dutasteride
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02839122
Brief Title
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuyu Pharma, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy male volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
Keywords
Dutasteride, Tadalafil
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dutasteride, Tadalafil
Arm Type
Experimental
Arm Title
Tadalafil, Dutasteride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Primary Outcome Measure Information:
Title
Area Under the Curve(AUC) of Dutasteride
Time Frame
0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours
Title
Area Under the Curve(AUC) of Tadalafil, Dutasteride
Time Frame
0,24,72,96,96.5,97,97.5,98,99,100,102,104,106,108,120,120.5,121,121.5,122,122.5,123,123.5,124,125,126,128,132,144,152,168,192,216,264,312,360 hours
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
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
Excessive alcohol consumption (> 3 units/week, 1 unit)
Taking food which may affect Clinical trial within 7 days
Positive result from Urinary test, Serum test
Not eligible due to other reasons including laboratory results
Clinically significant disorders result from Electrocardiography test
Not eligible due to investigator's judgments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hyeng-seok H Lim, ph.D
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
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