The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.

Study Overview
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Brief Summary
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The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.

Detailed Description
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A randomized, open-label, single dose, two-way crossover study.

Official Title
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Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.

Conditions
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LUTS(Lower Urinary Tract Symptoms), Benign Prostatic Hyperplasia, Overactive Bladder

Intervention / Treatment
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* Drug: JLP-1207
* Drug: Solifenacin 5mg+Tamsulosin 0.2mg


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: JLP-1207<br>JLP-1207 dosing in the fed state(high fat meal) | Drug: JLP-1207<br>* The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.<br>|
| Experimental: Solifenacin 5mg+Tamsulosin 0.2mg<br>Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal) | Drug: Solifenacin 5mg+Tamsulosin 0.2mg<br>* The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax |  | 192 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | 192 hours | 
| Tmax |  | 192 hours | 
| t1/2 |  | 192 hours | 
| CL/F |  | 192 hours | 
| Vd/f |  | 192 hours | 

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