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

Sponsor

Jeil Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02180997

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
LUTS Benign Prostatic Hyperplasia Overactive Bladder	Drug: Tamsulosin Drug: Solifenacin Drug: Tamsulosin and solifenacin	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin 1 Volunteers will be taken Tamsulosin and solifenacin	Drug: Solifenacin Tamsulosin and solifenacin: Solifenacin 10 mg, once daily Other Names: Vesicare tablet Drug: Tamsulosin and solifenacin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily Other Names: Harnal-D and Vesicare tablet
Experimental: Solifenacin 1 Volunteers will be taken Tamsulosin and solifenacin	Drug: Tamsulosin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily Other Names: Harnal-D tablet Drug: Tamsulosin and solifenacin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily Other Names: Harnal-D and Vesicare tablet
Experimental: Co-administration 1 Volunteers will be taken Tamsulosin and solifenacin	Drug: Tamsulosin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily Other Names: Harnal-D tablet Drug: Solifenacin Tamsulosin and solifenacin: Solifenacin 10 mg, once daily Other Names: Vesicare tablet
Experimental: Tamsulosin 2 Volunteers will be taken Tamsulosin and solifenacin	Drug: Solifenacin Tamsulosin and solifenacin: Solifenacin 10 mg, once daily Other Names: Vesicare tablet Drug: Tamsulosin and solifenacin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily Other Names: Harnal-D and Vesicare tablet
Experimental: Solifenacin 2 Volunteers will be taken Tamsulosin and solifenacin	Drug: Tamsulosin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily Other Names: Harnal-D tablet Drug: Tamsulosin and solifenacin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily Other Names: Harnal-D and Vesicare tablet
Experimental: Co-administration 2 Volunteers will be taken Tamsulosin and solifenacin	Drug: Tamsulosin Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily Other Names: Harnal-D tablet Drug: Solifenacin Tamsulosin and solifenacin: Solifenacin 10 mg, once daily Other Names: Vesicare tablet

Outcome Measures

Primary Outcome Measures

AUCτ,ss, Cmax,ss [192h]

Secondary Outcome Measures

C trough,ss [192h]
Tmax,ss [192h]
t1/2 [192h]
CL/F [192h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.