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

April 2, 2017 updated by: Yuyu Pharma, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve(AUC) of Dutasteride
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuyu Pharma, Inc.

Investigators

  • Principal Investigator: hyeng-seok H Lim, ph.D, AIDS Malignancy Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 23, 2016

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 2, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YY_DUTA_2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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