CompletedInterventionalPhase 1Updated Aug 20, 2015
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects | NCT02839122 | Trialant
CompletedInterventionalPhase 1Updated Apr 4, 2017
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
ClinicalTrials.gov ID
NCT02839122
Lead Sponsor
Yuyu Pharma, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
28Actual
Last Update Posted
Apr 4, 2017Actual
Start Date
May 2016
Primary Completion Date
Sep 2016Actual
Completion Date
Sep 23, 2016Actual
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.
Benign Prostate Hyperplasia
Tadalafil
Dutasteride
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
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