Benign Prostatic Hypertrophy (BPH)Phase 1NCT02615782
A Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 in Healthy Male Subjects
A Phase 1 study testing CKD-397 in people with Benign Prostatic Hypertrophy (BPH), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hypertrophy (BPH)
- What is being tested?
- CKD-397
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to May 2016
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subject older than 19 years at the time of screening.
- Subjects who BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- Subjects who signed the informed consent form after understanding fully to hear a detailed explanation in the clinical trial
Who cannot join
- Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who show AST or AST > 2 times upper limit of normal range or eGFR < 60 mL/min/1.73m2
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening
Show all 21Show fewer
- Subjects who have orthostatic hypotension
- Subjects who have history of drug abuse or drug abuse positive at screening
- Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- Smoker ( ≥ 20cigarettes/day)
- Subjects who takes ETC or herb medicine within two weeks or OTC or vitamin supplement within 1 week before the first IP administration
- Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing or receive blood transfusion within 1month prior to the first dosing
- Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results
- Subjects who take organic nitrate medicine regularly or intermittently
- Patients with genetic degenerative retinal disease including retinitis pigmentosa
- Subjects who have hypersensitivity to medicines including tadalafil/tamsulosin component or any other medicines(aspirin, antibiotics etc.) or medical history of clinically significant hypersensitivity
- Patients who lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy(NAION)
- Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects who use a trustworthy method of contraception
- Subjects who is not able to comply with guidelines described in the protocol
- Subjects who is determined by investigator's decision including laboratory test result or another reason as unsuitable for clinical trial participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 After a Single Oral Dose in Healthy Male Subjects
This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects
Read the detailed description
To healthy male subjects of sixteen(16), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.
Treatment A: CKD-397 1T under Fasting condition Treatment B: CKD-397 1T under Fed condition (high fat meals). Pharmacokinetic blood samples are collected up to 72hrs. Safety and pharmacokinetic are assessed.
- Conditions
- Benign Prostatic Hypertrophy (BPH)
- Being tested
- CKD-397
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-397Drug
Also called Tamsulosin HCl/Tadalafil 0.2/5mg, HARNAL-D Tab. 0.2mg + Cendom® Tab. 5mg
CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | 1. Period 1: CKD-397 1T single oral administration under fasting condition
2. Period 2: CKD-397 1T single oral administration under fed condition (high fat meals) Receives: Drug: CKD-397 |
| B group | Experimental | 1. Period 1: CKD-397 1T single oral administration under fed condition (high fat meals)
2. Period 2: CKD-397 1T single oral administration under fasting condition Receives: Drug: CKD-397 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Cmax of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Secondary outcomes (5)
AUCinf of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Tmax of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
t1/2 of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
CL/F of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Vd/F of Tadalafil and Tamsulosin
Measured: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hypertrophy (BPH)Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Kyu Park, MD, PhD, Principal investigator, Domg-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615782
- Sponsor's protocol ID
- 150FDI15031
- Status last verified
- Aug 2017
- First submitted
- 23 Nov 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 After a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02615782
- Acronym / sponsor ID
- 150FDI15031
- Conditions
- Benign Prostatic Hypertrophy (BPH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Nov 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 study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects
Detailed description
To healthy male subjects of sixteen(16), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.
Treatment A: CKD-397 1T under Fasting condition Treatment B: CKD-397 1T under Fed condition (high fat meals). Pharmacokinetic blood samples are collected up to 72hrs. Safety and pharmacokinetic are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: CKD-3971. Period 1: CKD-397 1T single oral administration under fasting condition 2. Period 2: CKD-397 1T single oral administration under fed condition (high fat meals) |
| B group | Experimental | Drug: CKD-3971. Period 1: CKD-397 1T single oral administration under fed condition (high fat meals) 2. Period 2: CKD-397 1T single oral administration under fasting condition |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male subject older than 19 years at the time of screening.
- Subjects who BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- Subjects who signed the informed consent form after understanding fully to hear a detailed explanation in the clinical trial
Key exclusion criteria (21 listed)
- Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- Subjects who show AST or AST > 2 times upper limit of normal range or eGFR < 60 mL/min/1.73m2
- Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
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 |
|---|---|---|
| CKD-397Also: Tamsulosin HCl/Tadalafil 0.2/5mg, HARNAL-D Tab. 0.2mg + Cendom® Tab. 5mgCKD-397 1T single oral administration under fasting condition or fed condition(high fat meals) | Drug | A group, B group |
Primary outcome
AUClast of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Cmax of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
5 secondary outcomes
AUCinf of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Tmax of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
t1/2 of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
CL/F of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
Vd/F of Tadalafil and Tamsulosin
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs
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 9 Aug 2017.
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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 Kyu Park, MD, PhD principal investigator
Domg-A 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 CKD-397 in people with Benign Prostatic Hypertrophy (BPH), run by Chong Kun Dang Pharmaceutical 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 3 inclusion and 21 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 9 Aug 2017. 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 of Tadalafil and Tamsulosin (time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72hrs). The study lists 2 primary outcomes in all. 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 9 Aug 2017.