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

Study Overview
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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.

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

Official Title
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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

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Solifenacin
* Drug: Tamsulosin and solifenacin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin 1<br>Volunteers will be taken Tamsulosin and solifenacin | Drug: Solifenacin<br>* Tamsulosin and solifenacin: Solifenacin 10 mg, once daily<br>* Other names: Vesicare tablet;Drug: Tamsulosin and solifenacin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily<br>* Other names: Harnal-D and Vesicare tablet;|
| Experimental: Solifenacin 1<br>Volunteers will be taken Tamsulosin and solifenacin | Drug: Tamsulosin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily<br>* Other names: Harnal-D tablet;Drug: Tamsulosin and solifenacin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily<br>* Other names: Harnal-D and Vesicare tablet;|
| Experimental: Co-administration 1<br>Volunteers will be taken Tamsulosin and solifenacin | Drug: Tamsulosin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily<br>* Other names: Harnal-D tablet;Drug: Solifenacin<br>* Tamsulosin and solifenacin: Solifenacin 10 mg, once daily<br>* Other names: Vesicare tablet;|
| Experimental: Tamsulosin 2<br>Volunteers will be taken Tamsulosin and solifenacin | Drug: Solifenacin<br>* Tamsulosin and solifenacin: Solifenacin 10 mg, once daily<br>* Other names: Vesicare tablet;Drug: Tamsulosin and solifenacin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily<br>* Other names: Harnal-D and Vesicare tablet;|
| Experimental: Solifenacin 2<br>Volunteers will be taken Tamsulosin and solifenacin | Drug: Tamsulosin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily<br>* Other names: Harnal-D tablet;Drug: Tamsulosin and solifenacin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily<br>* Other names: Harnal-D and Vesicare tablet;|
| Experimental: Co-administration 2<br>Volunteers will be taken Tamsulosin and solifenacin | Drug: Tamsulosin<br>* Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily<br>* Other names: Harnal-D tablet;Drug: Solifenacin<br>* Tamsulosin and solifenacin: Solifenacin 10 mg, once daily<br>* Other names: Vesicare tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss, Cmax,ss |  | 192h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C trough,ss |  | 192h | 
| Tmax,ss |  | 192h | 
| t1/2 |  | 192h | 
| CL/F |  | 192h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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α1-blockers, antimuscarinic agent