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

June 23, 2016 updated by: Jeil Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JLP-1207, Fasted followed by fed
JLP-1207 dosing in the fasted state followed by fed dosing
Drug: JLP-1207(Fasted)
Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.
Experimental: JLP-1207, Fed followed by fasted
JLP-1207 dosing in the fed state followed by fasted dosing
Drug: JLP-1207(Fed)
Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast, Cmax, AUCinf
Time Frame: 192 hours
192 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax
Time Frame: 192 hours
192 hours
t1/2
Time Frame: 192 hours
192 hours
CL/F
Time Frame: 192 hours
192 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Kyung-sang Yu, M.D., Ph.D., Seoul National University Hospital(SNUH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLP-1207-P1-FE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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