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

NCT02839122 | Completed Phase 1 DMC

• 1 other identifier: YY_DUTA_2016
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Benign Prostate Hyperplasia

Keywords

Dutasteride; Tadalafil

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Dutasteride, Tadalafil

EXPERIMENTAL

Drug: Tadalafil; Drug: Dutasteride

Tadalafil, Dutasteride

EXPERIMENTAL

Drug: Tadalafil; Drug: Dutasteride

Interventions

Tadalafil DRUG

Dutasteride, Tadalafil; Tadalafil, Dutasteride

Dutasteride DRUG

Dutasteride, Tadalafil; Tadalafil, Dutasteride

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuyu Pharma, Inc.: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil; Dutasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• hyeng-seok H Lim, ph.D

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: July 20, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 23, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share