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

Sponsor

Yuyu Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02839122

Collaborator

(none)

Enrollment

Arms

4.8

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostate Hyperplasia	Drug: Tadalafil Drug: Dutasteride	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 23, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dutasteride, Tadalafil	Drug: Tadalafil Drug: Dutasteride
Experimental: Tadalafil, Dutasteride	Drug: Tadalafil Drug: Dutasteride

Arm

Intervention/Treatment

Experimental: Dutasteride, Tadalafil

Drug: Tadalafil

Drug: Dutasteride

Experimental: Tadalafil, Dutasteride

Drug: Tadalafil

Drug: Dutasteride

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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