Safety and Pharmacokinetic Characteristics of DKF-313

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dongkook Pharmaceutical Co., Ltd.
• Treatments: Dutasteride; Tadalafil

Criteria

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-α 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