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

Primary Purpose

LUTS, Benign Prostatic Hyperplasia, Overactive Bladder

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Tamsulosin

Solifenacin

Tamsulosin and solifenacin

About this trial

This is an interventional treatment trial for LUTS focused on measuring α1-blockers, antimuscarinic agent

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Seoul National University Hospital(SNUH)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Tamsulosin 1

Solifenacin 1

Co-administration 1

Tamsulosin 2

Solifenacin 2

Co-administration 2

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Outcomes

Primary Outcome Measures

AUCτ,ss, Cmax,ss

Secondary Outcome Measures

C trough,ss

Tmax,ss

t1/2

CL/F

Full Information

NCT ID

NCT02180997

First Posted

July 1, 2014

Last Updated

June 23, 2016

Sponsor

Jeil Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02180997

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

LUTS, Benign Prostatic Hyperplasia, Overactive Bladder

Keywords

α1-blockers, antimuscarinic agent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tamsulosin 1

Arm Type

Experimental

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Arm Title

Solifenacin 1

Arm Type

Experimental

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Arm Title

Co-administration 1

Arm Type

Experimental

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Arm Title

Tamsulosin 2

Arm Type

Experimental

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Arm Title

Solifenacin 2

Arm Type

Experimental

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Arm Title

Co-administration 2

Arm Type

Experimental

Arm Description

Volunteers will be taken Tamsulosin and solifenacin

Intervention Type

Drug

Intervention Name(s)

Tamsulosin

Other Intervention Name(s)

Harnal-D tablet

Intervention Description

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Intervention Type

Drug

Intervention Name(s)

Solifenacin

Other Intervention Name(s)

Vesicare tablet

Intervention Description

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Intervention Type

Drug

Intervention Name(s)

Tamsulosin and solifenacin

Other Intervention Name(s)

Harnal-D and Vesicare tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

AUCτ,ss, Cmax,ss

Time Frame

192h

Secondary Outcome Measure Information:

Title

C trough,ss

Time Frame

192h

Title

Tmax,ss

Time Frame

192h

Title

t1/2

Time Frame

192h

Title

CL/F

Time Frame

192h

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Seoul National University Hospital(SNUH)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital(SNUH)

City

Seoul

State/Province

Jongno-Gu

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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