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

NCT ID: NCT02180997

Last Updated: 2016-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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

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Detailed Description

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

Conditions

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LUTS Benign Prostatic Hyperplasia Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tamsulosin 1

Volunteers will be taken Tamsulosin and solifenacin

Group Type EXPERIMENTAL

Solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Tamsulosin and solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Solifenacin 1

Volunteers will be taken Tamsulosin and solifenacin

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Tamsulosin and solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Co-administration 1

Volunteers will be taken Tamsulosin and solifenacin

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Tamsulosin 2

Volunteers will be taken Tamsulosin and solifenacin

Group Type EXPERIMENTAL

Solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Tamsulosin and solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Solifenacin 2

Volunteers will be taken Tamsulosin and solifenacin

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Tamsulosin and solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Co-administration 2

Volunteers will be taken Tamsulosin and solifenacin

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Solifenacin

Intervention Type DRUG

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Interventions

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Tamsulosin

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Intervention Type DRUG

Solifenacin

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Intervention Type DRUG

Tamsulosin and solifenacin

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Intervention Type DRUG

Other Intervention Names

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Harnal-D tablet Vesicare tablet Harnal-D and Vesicare tablet

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-sang Yu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital(SNUH)

Locations

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Seoul National University Hospital(SNUH)

Seoul, Jongno-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JLP-1207-P1-DI

Identifier Type: -

Identifier Source: org_study_id

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