Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

Benign Prostate Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942551
• Other study ID #: DK-DT-001
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2013
• Last updated: January 22, 2015
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Dongkook Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 29 Years

Eligibility

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-a 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tadalafil

• Dutasteride

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under Curve (AUC) of tadalafil		0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h	No
Primary	Cmax of tadalafil		0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h	No
Primary	Area Under Curve (AUC) of dutasteride		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	No
Primary	Cmax of dutasteride		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	No