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Trial record 38 of 117 for:    DUTASTERIDE

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

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ClinicalTrials.gov Identifier: NCT02839122
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Yuyu Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Benign Prostate Hyperplasia Drug: Tadalafil Drug: Dutasteride Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : May 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 23, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dutasteride, Tadalafil Drug: Tadalafil
Drug: Dutasteride
Experimental: Tadalafil, Dutasteride Drug: Tadalafil
Drug: Dutasteride



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839122


Sponsors and Collaborators
Yuyu Pharma, Inc.
Investigators
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Principal Investigator: hyeng-seok H Lim, ph.D AIDS Malignancy Consortium

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Responsible Party: Yuyu Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02839122     History of Changes
Other Study ID Numbers: YY_DUTA_2016
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Yuyu Pharma, Inc.:
Dutasteride
Tadalafil
Additional relevant MeSH terms:
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Dutasteride
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs