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Safety and Pharmacokinetic Characteristics of DKF-313

Sponsor
Dongkook Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02352311
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jan 1, 2015
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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 Names:
  • Dutasteride

    • Drug: CIALIS
    Tadalafil 5 mg
    Other Names:
  • 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 Names:
  • Dutasteride

    • Drug: CIALIS
    Tadalafil 5 mg
    Other Names:
  • Tadalafil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 29 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Chonbuk National University Hospital Jeonju Jeollabuk-do Korea, Republic of 561-712

    Sponsors and Collaborators

    • Dongkook Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Min-Gul Kim, M.D., Chonbuk National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dongkook Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02352311
    Other Study ID Numbers:
    • DK-DT-002
    First Posted:
    Feb 2, 2015
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tadalafil
    Dutasteride

    Study Results

    No Results Posted as of Jul 6, 2021