A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects

Yuyu Pharma

Status and phase

Completed

Phase 1

Conditions

Benign Prostate Hyperplasia

Treatments

Drug: Tadalafil

Drug: Dutasteride

Study type

Interventional

Funder types

Industry

Identifiers

NCT02839122

YY_DUTA_2016

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts 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
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