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NCT02352311 Clinical Trial

Safety and Pharmacokinetic Characteristics of DKF-313

Healthy Clinical Trial

Official title:
A Randomized, Open-label, Single-dose, 2-treatment, 2-way, 2-period Crossover Study to Evaluate the Safety and the Pharmacokinetic Characteristics of DKF-313 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02352311
Other study ID # DK-DT-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2015
Est. completion date June 2015

Study information
Verified date February 2015
Source Dongkook Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.

Description:

This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and tadalafil) comparing with the concomitant administration of AVODART and CIALIS in healthy male volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 29 Years
Eligibility Inclusion Criteria: 1. Age 19 to 29 years 2. BMI 17.5 to 30.5 kg/m2 and body weight 55 kg or more 3. No congenital or chronic diseases within 3 years, no disease symptoms or findings 4. Eligible according to the laboratory results of hematology, blood chemistry and urinalysis and ECG 5. Voluntarily signed the informed consent form 6. Willing to participate in the study Exclusion Criteria: 1. Clinically significant disorders of blood, kidney, endocrine, respiratory system, gastrointestinal system, urology, cardiovascular system, liver, psychiatry, neurology or allergy 2. Gastrointestinal diseases or surgery which may affect absorption of the investigational products 3. ALT or AST > 2xULN 4. Excessive alcohol consumption (> 210 g/week) within 6 months 5. Participated and administered the investigational products in other clinical trial within 2 months 6. SBP = 100 mmHg or = 150 mmHg or DBP = 60 mmHg or = 100 mmHg 7. History or positive result of serious alcohol or drug abuse within 1 year 8. Drugs which induce or inhibit drug metabolism within 1 month 9. Smoked more than 10 cigarettes a day 10. Prescribed drugs or over-the counter drugs within 10 days 11. Donated whole blood within 2 months or apheresis within 1 month 12. Severe acute/chronic medical and mental conditions or lab abnormalities which may increase the risk or interfere in the interpretation of study results 13. Hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-a reductase inhibitor, or other drugs including aspirin, antibiotics, etc. 14. Galactose intolerance, fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 15. CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks 16. Myocardial infarction within 90 days 17. Unstable angina or angina during sexual intercourse 18. Heart failure (New York Heart Association Class 2 or higher) within 6 months 19. Uncontrolled arrhythmias 20. Stroke within 6 months 21. Inherited retinal degeneration including retinitis pigmentosa 22. Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION) 23. Plans to donate blood for at least 6 months after final dose of the investigational products 24. Unwilling to comply with the lifestyle guidelines in the protocol 25. Not eligible due to other reasons at the investigator's discretion

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg
• AVODART
Dutasteride 0.5 mg
• CIALIS
Tadalafil 5 mg

Locations
Country Name City State
Korea, Republic of Chonbuk National University Hospital Jeonju Jeollabuk-do

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 AUClast and Cmax of dutasteride and tadalafil 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192 h
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