Overview
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
Status:
Completed
Completed
Trial end date:
2016-09-23
2016-09-23
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Yuyu Pharma, Inc.Treatments:
Dutasteride
Tadalafil
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