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

Benign Prostate Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839122
• Other study ID #: YY_DUTA_2016
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2016
• Last updated: April 2, 2017
• Start date: May 2016
• Est. completion date: September 23, 2016

Study information

• Verified date: April 2017
• Source: Yuyu Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 23, 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tadalafil

• Dutasteride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuyu Pharma, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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