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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02839122

Enrollment

Registered

2016-07-20

Start date

2016-05-31

Completion date

2016-09-23

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

Keywords

Dutasteride, Tadalafil

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.

Interventions

DRUGTadalafil

DRUGDutasteride

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026