Benign Prostate HyperplasiaPhase 1NCT02352311
Safety and Pharmacokinetic Characteristics of DKF-313
A Phase 1 study testing DKF-313, AVODART and CIALIS in people with Benign Prostate Hyperplasia and Healthy, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostate Hyperplasia, Healthy
- What is being tested?
- DKF-313, AVODART and CIALIS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
About this study
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
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.
Read the 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.
- Conditions
- Benign Prostate Hyperplasia, Healthy
- Being tested
- DKF-313, AVODART, CIALIS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKF-313Drug
Combination of dutasteride 0.5 mg and tadalafil 5 mg
AVODARTDrug
Also called Dutasteride
Dutasteride 0.5 mg
CIALISDrug
Also called Tadalafil
Tadalafil 5 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DKF-313; Drug: AVODART; Drug: 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. Receives: Drug: DKF-313; Drug: AVODART; Drug: CIALIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast and Cmax of dutasteride and tadalafil
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, M.D., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352311
- Sponsor's protocol ID
- DK-DT-002
- Status last verified
- Feb 2015
- First submitted
- 22 Jan 2015
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02352311
- Acronym / sponsor ID
- DK-DT-002
- Conditions
- Benign Prostate Hyperplasia, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 AVODART, CIALIS, DKF-313 | Experimental | Drug: DKF-313, Drug: AVODART, Drug: CIALISIn 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 2 DKF-313, AVODART, CIALIS | Experimental | Drug: DKF-313, Drug: AVODART, Drug: CIALISIn 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. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKF-313Combination of dutasteride 0.5 mg and tadalafil 5 mg | Drug | Arm 1 AVODART, CIALIS, DKF-313, Arm 2 DKF-313, AVODART, CIALIS |
| AVODARTAlso: DutasterideDutasteride 0.5 mg | Drug | Arm 1 AVODART, CIALIS, DKF-313, Arm 2 DKF-313, AVODART, CIALIS |
| CIALISAlso: TadalafilTadalafil 5 mg | Drug | Arm 1 AVODART, CIALIS, DKF-313, Arm 2 DKF-313, AVODART, CIALIS |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
Related trials for Benign Prostate Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Gul Kim, M.D. principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DKF-313, AVODART and CIALIS in people with Benign Prostate Hyperplasia and Healthy, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.