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

Phase 1

Completed

• Conditions: Overactive Bladder; LUTS; Benign Prostatic Hyperplasia
• Interventions: Drug: JLP-1207(Fasted); Drug: JLP-1207(Fed)

• Registration Number: NCT02447367
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-18
• Status Verified: 2015-06
• Study Start: 2015-07
• Primary Completion: 2015-09
• 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
JLP-1207, Fasted followed by fed	JLP-1207(Fasted)	JLP-1207 dosing in the fasted state followed by fed dosing
JLP-1207, Fed followed by fasted	JLP-1207(Fed)	JLP-1207 dosing in the fed state followed by fasted dosing

Primary Outcome Measures

Name	Time	Method
AUClast, Cmax, AUCinf	192 hours

Secondary Outcome Measures

Name	Time	Method
Tmax	192 hours
t1/2	192 hours
CL/F	192 hours