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Safety and Pharmacokinetic Characteristics of DKF-313

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ClinicalTrials.gov Identifier: NCT02352311
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
Dongkook Pharmaceutical Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Benign Prostate Hyperplasia Healthy Drug: DKF-313 Drug: AVODART Drug: CIALIS Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg

Drug: AVODART
Dutasteride 0.5 mg
Other Name: Dutasteride

Drug: CIALIS
Tadalafil 5 mg
Other Name: Tadalafil
Experimental: 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.
 Drug: DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg

Drug: AVODART
Dutasteride 0.5 mg
Other Name: Dutasteride

Drug: CIALIS
Tadalafil 5 mg
Other Name: Tadalafil


Outcome Measures
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Primary Outcome Measures :
  1. AUClast and Cmax of dutasteride and tadalafil [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192 h ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352311


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
Dongkook Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Min-Gul Kim, M.D. Chonbuk National University Hospital
More Information
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Responsible Party: Dongkook Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02352311    
Other Study ID Numbers: DK-DT-002
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: February 2015
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Tadalafil
Dutasteride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs