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

Yuyu Pharma, Inc.0 sites28 target enrollmentMay 2016

ConditionsBenign Prostate Hyperplasia

InterventionsTadalafil Dutasteride

DrugsTadalafil Dutasteride

Overview

Phase: Phase 1
Intervention: Tadalafil
Conditions: Benign Prostate Hyperplasia
Sponsor: Yuyu Pharma, Inc.
Enrollment: 28
Primary Endpoint: Area Under the Curve(AUC) of Tadalafil, Dutasteride
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

September 23, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Yuyu Pharma, Inc.

Responsible Party

Sponsor

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

Arms & Interventions

Dutasteride, Tadalafil

Intervention: Tadalafil

Dutasteride, Tadalafil

Intervention: Dutasteride

Tadalafil, Dutasteride

Intervention: Tadalafil

Tadalafil, Dutasteride

Intervention: Dutasteride

Outcomes

Primary Outcomes

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

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