Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers

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

Official Title
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Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers

Conditions
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LUTS, Benign Prostatic Hyperplasia, Overactive Bladder

Intervention / Treatment
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* Drug: JLP-1207(Fasted)
* Drug: JLP-1207(Fed)


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, Fasted followed by fed<br>JLP-1207 dosing in the fasted state followed by fed dosing | Drug: JLP-1207(Fasted)<br>* Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.<br>|
| Experimental: JLP-1207, Fed followed by fasted<br>JLP-1207 dosing in the fed state followed by fasted dosing | Drug: JLP-1207(Fed)<br>* Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 192 hours | 
| t1/2 |  | 192 hours | 
| CL/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