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

Phase 1

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Drug: Tadalafil; Drug: Dutasteride

• Registration Number: NCT02839122
• Lead Sponsor: Yuyu Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-20
• Primary Completion: 2016-09
• Study Completion: 2016-09-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-02
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tadalafil, Dutasteride	Dutasteride	-
Dutasteride, Tadalafil	Dutasteride	-
Dutasteride, Tadalafil	Tadalafil	-
Tadalafil, Dutasteride	Tadalafil	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve(AUC) of Tadalafil, Dutasteride	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	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