LUTS(Lower Urinary Tract Symptoms)Phase 1NCT02494349
The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.
A Phase 1 study testing JLP-1207 and Solifenacin 5mg+Tamsulosin 0.2mg in people with LUTS(Lower Urinary Tract Symptoms) and Benign Prostatic Hyperplasia, run by Jeil Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- LUTS(Lower Urinary Tract Symptoms), Benign Prostatic Hyperplasia, Overactive Bladder
- What is being tested?
- JLP-1207 and Solifenacin 5mg+Tamsulosin 0.2mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19~45 years healthy male
- Body weight is over 55kg, BMI measurement 18.0kg/m^2~ 27.0kg/m^2
- Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
- Researchers determined suitable volunteers through physical examination, laboratory tests
Who cannot join
- History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
- Sitting SBP>150mmHg or <100mmHg, sitting DBP>100mmHg or <60mmHg, after 3 minutes break
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
- History of drug abuse
- Positive urine drug screening
- Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
- Donated blood within 60 days prior to the first administration day in this study.
About this study
Official title: Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.
The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.
Read the detailed description
A randomized, open-label, single dose, two-way crossover study.
- Being tested
- JLP-1207, Solifenacin 5mg+Tamsulosin 0.2mg
- Keywords
- α1-blockers, antimuscarinic agent
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JLP-1207Drug
The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.
Solifenacin 5mg+Tamsulosin 0.2mgDrug
The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.
| Study group | Role | What they receive |
|---|---|---|
| JLP-1207 | Experimental | JLP-1207 dosing in the fed state(high fat meal) Receives: Drug: JLP-1207 |
| Solifenacin 5mg+Tamsulosin 0.2mg | Experimental | Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal) Receives: Drug: Solifenacin 5mg+Tamsulosin 0.2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast, Cmax
Measured: 192 hours
Secondary outcomes (5)
AUCinf
Measured: 192 hours
Tmax
Measured: 192 hours
t1/2
Measured: 192 hours
CL/F
Measured: 192 hours
Vd/f
Measured: 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUTS(Lower Urinary Tract Symptoms)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-sang Yu, M.D., Ph.D., Principal investigator, Seoul National University Hospital(SNUH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494349
- Sponsor's protocol ID
- JLP-1207-P1-PK
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT02494349
- Acronym / sponsor ID
- JLP-1207-P1-PK
- Keywords
- α1-blockers, antimuscarinic agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 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.
The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.
Detailed description
A randomized, open-label, single dose, two-way crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JLP-1207 | Experimental | Drug: JLP-1207JLP-1207 dosing in the fed state(high fat meal) |
| Solifenacin 5mg+Tamsulosin 0.2mg | Experimental | Drug: Solifenacin 5mg+Tamsulosin 0.2mgSolifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 19~45 years healthy male
- Body weight is over 55kg, BMI measurement 18.0kg/m^2~ 27.0kg/m^2
- Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
- Researchers determined suitable volunteers through physical examination, laboratory tests
Key exclusion criteria (8 listed)
- History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
- Sitting SBP>150mmHg or <100mmHg, sitting DBP>100mmHg or <60mmHg, after 3 minutes break
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
- History of drug abuse
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 |
|---|---|---|
| JLP-1207The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. | Drug | JLP-1207 |
| Solifenacin 5mg+Tamsulosin 0.2mgThe subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition. | Drug | Solifenacin 5mg+Tamsulosin 0.2mg |
Primary outcome
AUClast, Cmax
Time frame: 192 hours
5 secondary outcomes
AUCinf
Time frame: 192 hours
Tmax
Time frame: 192 hours
t1/2
Time frame: 192 hours
CL/F
Time frame: 192 hours
Vd/f
Time frame: 192 hours
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 24 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Kyung-sang Yu, M.D., Ph.D. principal investigator
Seoul National University Hospital(SNUH)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JLP-1207 and Solifenacin 5mg+Tamsulosin 0.2mg in people with LUTS(Lower Urinary Tract Symptoms) and Benign Prostatic Hyperplasia, run by Jeil Pharmaceutical Co., Ltd..
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 4 inclusion and 8 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 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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, Cmax (time frame: 192 hours). 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 24 Jun 2016.