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Trial record 68 of 117 for:    DUTASTERIDE

Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

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ClinicalTrials.gov Identifier: NCT01942551
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Dongkook Pharmaceutical Co., Ltd.

Brief Summary:
This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of tadalafil and dutasteride 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 : 47 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : September 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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



Primary Outcome Measures :
  1. Area Under Curve (AUC) of tadalafil [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h ]
  2. Cmax of tadalafil [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h ]
  3. Area Under Curve (AUC) of dutasteride [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48, 72, 96, 144, 192, 240, 288, 336 h ]
  4. Cmax of dutasteride [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48, 72, 96, 144, 192, 240, 288, 336 h ]


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Ages Eligible for Study:   20 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age 20 to 29 years 2. Weight 60 kg or more, within 20% of Ideal body weight 3. No congenital or chronic diseases, no disease symptoms or findings 4. Eligible according to the laboratory results of hematology, blood chemistry and urinalysis 5. Voluntarily signed the informed consent form

Exclusion Criteria:

  • 1. Clinically significant disorders of hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system 2. Gastrointestinal diseases or surgery which may affect absorption of the investigational products 3. hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor 4. Lactose intolerance 5. SBP ≥ 140 mmHg or < 90 mmHg or DBP ≥ 95 mmHg or < 60 mmHg 6. Serum creatinine > ULN 7. History or positive result of drug abuse 8. Drugs which induce or inhibit drug metabolism including barbiturates within 1 month 9. Prescribed drugs or herbal medicines within 2 weeks, or over-the counter drugs or vitamins within 1 week 10. CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks 11. Food including grapefruit from Week -1 to final dose 12. Participated and administered the investigational products in other clinical trial within 2 months 13. Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month 14. Plans to donate blood for at least 6 months after final dose of dutasteride 15. Scheduled dental treatment and elective surgery from informed consent to post-study visit 16. Excessive alcohol consumption (> 21 units/week, 1 unit = 10 g of pure alcohol) 17. Smoked more than 10 cigarettes a day for past 3 months 18. Not eligible due to other reasons including laboratory results

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): NCT01942551


Locations
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Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
Dongkook Pharmaceutical Co., Ltd.

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Responsible Party: Dongkook Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01942551     History of Changes
Other Study ID Numbers: DK-DT-001
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
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