LUTSPhase 1NCT02180997

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

A Phase 1 study testing Tamsulosin, Solifenacin and Tamsulosin and solifenacin in people with LUTS and Benign Prostatic Hyperplasia, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the pharmacokinetic drug interaction 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, Benign Prostatic Hyperplasia, Overactive Bladder
What is being tested?: Tamsulosin, Solifenacin and Tamsulosin and solifenacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: Jul 2014to Mar 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital(SNUH)
Seoul, Jongno-Gu, 110-744

Other trials in South Korea

About this study

Official title: Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Read the detailed description

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

Conditions: LUTS, Benign Prostatic Hyperplasia, Overactive Bladder
Being tested: Tamsulosin, Solifenacin, Tamsulosin and solifenacin
Keywords: α1-blockers, antimuscarinic agent
Medical subject headings: Prostatic Hyperplasia, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TamsulosinDrug
Also called Harnal-D tablet
Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily
SolifenacinDrug
Also called Vesicare tablet
Tamsulosin and solifenacin: Solifenacin 10 mg, once daily
Tamsulosin and solifenacinDrug
Also called Harnal-D and Vesicare tablet
Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Study groups in NCT02180997
Study group	Role	What they receive
Tamsulosin 1	Experimental	Volunteers will be taken Tamsulosin and solifenacin Receives: Drug: Solifenacin; Drug: Tamsulosin and solifenacin
Solifenacin 1	Experimental	Volunteers will be taken Tamsulosin and solifenacin Receives: Drug: Tamsulosin; Drug: Tamsulosin and solifenacin
Co-administration 1	Experimental	Volunteers will be taken Tamsulosin and solifenacin Receives: Drug: Tamsulosin; Drug: Solifenacin
Tamsulosin 2	Experimental	Volunteers will be taken Tamsulosin and solifenacin Receives: Drug: Solifenacin; Drug: Tamsulosin and solifenacin
Solifenacin 2	Experimental	Volunteers will be taken Tamsulosin and solifenacin Receives: Drug: Tamsulosin; Drug: Tamsulosin and solifenacin
Co-administration 2	Experimental	Volunteers will be taken Tamsulosin and solifenacin Receives: Drug: Tamsulosin; Drug: Solifenacin

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCτ,ss, Cmax,ss
Measured: 192h

Secondary outcomes (4)

C trough,ss
Measured: 192h
Tmax,ss
Measured: 192h
t1/2
Measured: 192h
CL/F
Measured: 192h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Mar 2015

First posted3 Jul 2014 (estimated)
Study startJul 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LUTSStudies 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180997
Sponsor's protocol ID: JLP-1207-P1-DI
Status last verified: Jul 2014
First submitted: 1 Jul 2014
Last updated: 24 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Lower Urinary Tract Symptoms (LUTS)
Active, not recruitingPhase 1
RT-310 Dose Escalation BPH Study
BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)

All LUTS trials

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: Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02180997
Acronym / sponsor ID: JLP-1207-P1-DI
Conditions: LUTS, Benign Prostatic Hyperplasia, Overactive Bladder
Keywords: α1-blockers, antimuscarinic agent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 3 Jul 2014 (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 the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Detailed description

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Tamsulosin 1	Experimental	Drug: Solifenacin, Drug: Tamsulosin and solifenacinVolunteers will be taken Tamsulosin and solifenacin
Solifenacin 1	Experimental	Drug: Tamsulosin, Drug: Tamsulosin and solifenacinVolunteers will be taken Tamsulosin and solifenacin
Co-administration 1	Experimental	Drug: Tamsulosin, Drug: SolifenacinVolunteers will be taken Tamsulosin and solifenacin
Tamsulosin 2	Experimental	Drug: Solifenacin, Drug: Tamsulosin and solifenacinVolunteers will be taken Tamsulosin and solifenacin
Solifenacin 2	Experimental	Drug: Tamsulosin, Drug: Tamsulosin and solifenacinVolunteers will be taken Tamsulosin and solifenacin
Co-administration 2	Experimental	Drug: Tamsulosin, Drug: SolifenacinVolunteers will be taken Tamsulosin and solifenacin

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
TamsulosinAlso: Harnal-D tabletTamsulosin and solifenacin: Tamsulosin 0.4mg, once daily	Drug	Co-administration 1, Co-administration 2, Solifenacin 1, Solifenacin 2
SolifenacinAlso: Vesicare tabletTamsulosin and solifenacin: Solifenacin 10 mg, once daily	Drug	Co-administration 1, Co-administration 2, Tamsulosin 1, Tamsulosin 2
Tamsulosin and solifenacinAlso: Harnal-D and Vesicare tabletTamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily	Drug	Solifenacin 1, Solifenacin 2, Tamsulosin 1, Tamsulosin 2

Primary outcome

AUCτ,ss, Cmax,ss
Time frame: 192h

4 secondary outcomes

C trough,ss
Time frame: 192h
Tmax,ss
Time frame: 192h
t1/2
Time frame: 192h
CL/F
Time frame: 192h

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

Related trials for LUTS

Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Lower Urinary Tract Symptoms (LUTS)
Active, not recruitingPhase 1
RT-310 Dose Escalation BPH Study
BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)

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)

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 Tamsulosin, Solifenacin and Tamsulosin and solifenacin in people with LUTS and Benign Prostatic Hyperplasia, run by Jeil 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 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.

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?

AUCτ,ss, Cmax,ss (time frame: 192h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02180997.

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.