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

Primary Purpose

LUTS, Benign Prostatic Hyperplasia, Overactive Bladder

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

JLP-1207(Fasted)

JLP-1207(Fed)

About this trial

This is an interventional treatment trial for LUTS focused on measuring α1-blockers, antimuscarinic agent

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

JLP-1207, Fasted followed by fed

JLP-1207, Fed followed by fasted

Arm Description

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

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

Outcomes

Primary Outcome Measures

AUClast, Cmax, AUCinf

Secondary Outcome Measures

Tmax

t1/2

CL/F

Full Information

NCT ID

NCT02447367

First Posted

May 14, 2015

Last Updated

June 23, 2016

Sponsor

Jeil Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02447367

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

LUTS, Benign Prostatic Hyperplasia, Overactive Bladder

Keywords

α1-blockers, antimuscarinic agent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JLP-1207, Fasted followed by fed

Arm Type

Experimental

Arm Description

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

Arm Title

JLP-1207, Fed followed by fasted

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

JLP-1207(Fasted)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

JLP-1207(Fed)

Intervention Description

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

Primary Outcome Measure Information:

Title

AUClast, Cmax, AUCinf

Time Frame

192 hours

Secondary Outcome Measure Information:

Title

Tmax

Time Frame

192 hours

Title

t1/2

Time Frame

192 hours

Title

CL/F

Time Frame

192 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Seoul National University Hospital(SNUH)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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