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

NCT ID: NCT02839122

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-09-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dutasteride, Tadalafil

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Dutasteride

Intervention Type: DRUG

Tadalafil, Dutasteride

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Dutasteride

Intervention Type: DRUG

Interventions

Tadalafil

Intervention Type: DRUG

Dutasteride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuyu Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hyeng-seok H Lim, ph.D

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Other Identifiers

YY_DUTA_2016

Identifier Type: -

Identifier Source: org_study_id