NCT02352311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 6, 2021

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

January 22, 2015

Last Update Submit

July 1, 2021

Conditions

Benign Prostate HyperplasiaHealthy

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Arm 1 AVODART, CIALIS, DKF-313

EXPERIMENTAL

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-313Drug: AVODARTDrug: CIALIS

Arm 2 DKF-313, AVODART, CIALIS

EXPERIMENTAL

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-313Drug: AVODARTDrug: CIALIS

Interventions

DKF-313DRUG

Combination of dutasteride 0.5 mg and tadalafil 5 mg

Arm 1 AVODART, CIALIS, DKF-313Arm 2 DKF-313, AVODART, CIALIS
AVODARTDRUG

Dutasteride 0.5 mg

Also known as: Dutasteride
Arm 1 AVODART, CIALIS, DKF-313Arm 2 DKF-313, AVODART, CIALIS
CIALISDRUG

Tadalafil 5 mg

Also known as: Tadalafil
Arm 1 AVODART, CIALIS, DKF-313Arm 2 DKF-313, AVODART, CIALIS

Eligibility Criteria

Age19 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

DutasterideTadalafil

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic CompoundsCarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Min-Gul Kim, M.D.

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 2, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 6, 2021

Record last verified: 2015-02

Locations

KR(1)