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

Phase 1

Completed

• Conditions: Overactive Bladder; Benign Prostatic Hyperplasia; LUTS(Lower Urinary Tract Symptoms)
• Interventions: Drug: Solifenacin 5mg+Tamsulosin 0.2mg; Drug: JLP-1207

• Registration Number: NCT02494349
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

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

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Study Start: 2015-08
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Solifenacin 5mg+Tamsulosin 0.2mg	Solifenacin 5mg+Tamsulosin 0.2mg	Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)
JLP-1207	JLP-1207	JLP-1207 dosing in the fed state(high fat meal)

Primary Outcome Measures

Name	Time	Method
AUClast, Cmax	192 hours

Secondary Outcome Measures

Name	Time	Method
t1/2	192 hours
Tmax	192 hours
AUCinf	192 hours
Vd/f	192 hours
CL/F	192 hours