NCT02447367

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

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

• 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 the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Detailed description

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

Conditions

• LUTS
• Benign Prostatic Hyperplasia
• Overactive Bladder

Interventions

Type	Name	Description
DRUG	JLP-1207(Fasted)	Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.
DRUG	JLP-1207(Fed)	Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2015-05-18
• Last updated: 2016-06-24