NCT02494349

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Jeil Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	JLP-1207	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.
DRUG	Solifenacin 5mg+Tamsulosin 0.2mg	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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-07-10
• Last updated: 2016-06-24