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

Y

Yuyu Pharma

Status and phase

Completed
Phase 1

Conditions

Benign Prostate Hyperplasia

Treatments

Drug: Tadalafil
Drug: Dutasteride

Study type

Interventional

Funder types

Industry

Identifiers

NCT02839122
YY_DUTA_2016

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Dutasteride, Tadalafil
Experimental group
Treatment:
Drug: Dutasteride
Drug: Tadalafil
Tadalafil, Dutasteride
Experimental group
Treatment:
Drug: Dutasteride
Drug: Tadalafil

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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