Safety and Pharmacokinetic Characteristics of DKF-313

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.

Inclusion criteria

• Age 19 to 29 years
• BMI 17.5 to 30.5 kg/m2 and body weight 55 kg or more
• No congenital or chronic diseases within 3 years, no disease symptoms or findings
• Eligible according to the laboratory results of hematology, blood chemistry and urinalysis and ECG
• Voluntarily signed the informed consent form 6. Willing to participate in the study

Exclusion criteria

• Clinically significant disorders of blood, kidney, endocrine, respiratory system, gastrointestinal system, urology, cardiovascular system, liver, psychiatry, neurology or allergy
• Gastrointestinal diseases or surgery which may affect absorption of the investigational products
• ALT or AST > 2xULN
• Excessive alcohol consumption (> 210 g/week) within 6 months
• Participated and administered the investigational products in other clinical trial within 2 months
• SBP ≤ 100 mmHg or ≥ 150 mmHg or DBP ≤ 60 mmHg or ≥ 100 mmHg
• History or positive result of serious alcohol or drug abuse within 1 year
• Drugs which induce or inhibit drug metabolism within 1 month
• Smoked more than 10 cigarettes a day
• Prescribed drugs or over-the counter drugs within 10 days
• Donated whole blood within 2 months or apheresis within 1 month
• Severe acute/chronic medical and mental conditions or lab abnormalities which may increase the risk or interfere in the interpretation of study results
• Hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor, or other drugs including aspirin, antibiotics, etc.
• Galactose intolerance, fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks
• Myocardial infarction within 90 days
• Unstable angina or angina during sexual intercourse
• Heart failure (New York Heart Association Class 2 or higher) within 6 months
• Uncontrolled arrhythmias
• Stroke within 6 months
• Inherited retinal degeneration including retinitis pigmentosa
• Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
• Plans to donate blood for at least 6 months after final dose of the investigational products
• Unwilling to comply with the lifestyle guidelines in the protocol
• Not eligible due to other reasons at the investigator's discretion