Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2015-01-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Arm 1 AVODART, CIALIS, DKF-313
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.
DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg
AVODART
Dutasteride 0.5 mg
CIALIS
Tadalafil 5 mg
Arm 2 DKF-313, AVODART, CIALIS
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.
DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg
AVODART
Dutasteride 0.5 mg
CIALIS
Tadalafil 5 mg
Interventions
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DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg
AVODART
Dutasteride 0.5 mg
CIALIS
Tadalafil 5 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
29 Years
MALE
Yes
Sponsors
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Dongkook Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Min-Gul Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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DK-DT-002
Identifier Type: -
Identifier Source: org_study_id
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