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Safety and Pharmacokinetic Characteristics of DKF-313

Primary Purpose

Benign Prostate Hyperplasia, Healthy

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DKF-313
AVODART
CIALIS
Sponsored by
Dongkook Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Benign Prostate Hyperplasia

Eligibility Criteria

19 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1 AVODART, CIALIS, DKF-313

Arm 2 DKF-313, AVODART, CIALIS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

AUClast and Cmax of dutasteride and tadalafil

Secondary Outcome Measures

Full Information

First Posted
January 22, 2015
Last Updated
July 1, 2021
Sponsor
Dongkook Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02352311
Brief Title
Safety and Pharmacokinetic Characteristics of DKF-313
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongkook Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia, Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 AVODART, CIALIS, DKF-313
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2 DKF-313, AVODART, CIALIS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DKF-313
Intervention Description
Combination of dutasteride 0.5 mg and tadalafil 5 mg
Intervention Type
Drug
Intervention Name(s)
AVODART
Other Intervention Name(s)
Dutasteride
Intervention Description
Dutasteride 0.5 mg
Intervention Type
Drug
Intervention Name(s)
CIALIS
Other Intervention Name(s)
Tadalafil
Intervention Description
Tadalafil 5 mg
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Gul Kim, M.D.
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of

12. IPD Sharing Statement

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Safety and Pharmacokinetic Characteristics of DKF-313

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