Safety and Pharmacokinetic Characteristics of DKF-313

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Benign Prostate Hyperplasia, Healthy

Intervention / Treatment
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* Drug: DKF-313
* Drug: AVODART
* Drug: CIALIS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 AVODART, CIALIS, DKF-313<br>In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. | Drug: DKF-313<br>* Combination of dutasteride 0.5 mg and tadalafil 5 mg<br>Drug: AVODART<br>* Dutasteride 0.5 mg<br>* Other names: Dutasteride;Drug: CIALIS<br>* Tadalafil 5 mg<br>* Other names: Tadalafil;|
| Experimental: Arm 2 DKF-313, AVODART, CIALIS<br>In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. | Drug: DKF-313<br>* Combination of dutasteride 0.5 mg and tadalafil 5 mg<br>Drug: AVODART<br>* Dutasteride 0.5 mg<br>* Other names: Dutasteride;Drug: CIALIS<br>* Tadalafil 5 mg<br>* Other names: Tadalafil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |