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

NCT ID: NCT02447367

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

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

Conditions

LUTS; Benign Prostatic Hyperplasia; Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JLP-1207, Fasted followed by fed

JLP-1207 dosing in the fasted state followed by fed dosing

Group Type: EXPERIMENTAL

JLP-1207(Fasted)

Intervention Type: DRUG

Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.

JLP-1207, Fed followed by fasted

JLP-1207 dosing in the fed state followed by fasted dosing

Group Type: EXPERIMENTAL

JLP-1207(Fed)

Intervention Type: DRUG

Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition

Interventions

JLP-1207(Fasted)

Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.

Intervention Type: DRUG

JLP-1207(Fed)

Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-sang Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital(SNUH)

Other Identifiers

JLP-1207-P1-FE

Identifier Type: -

Identifier Source: org_study_id