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

NCT02447367 | Completed Phase 1

• 1 other identifier: JLP-1207-P1-FE
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

LUTS; Benign Prostatic Hyperplasia; Overactive Bladder

Keywords

α1-blockers; antimuscarinic agent

Outcome Measures

Primary Outcomes (1)

• AUClast, Cmax, AUCinf

  192 hours

Secondary Outcomes (3)

• Tmax

  192 hours

• t1/2

  192 hours

• CL/F

  192 hours

Study Arms (2)

JLP-1207, Fasted followed by fed

EXPERIMENTAL

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

Drug: JLP-1207(Fasted)

JLP-1207, Fed followed by fasted

EXPERIMENTAL

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

Drug: JLP-1207(Fed)

Interventions

JLP-1207(Fasted) DRUG

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

JLP-1207, Fasted followed by fed

JLP-1207(Fed) DRUG

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

JLP-1207, Fed followed by fasted

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \~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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyung-sang Yu, M.D., Ph.D.

  Seoul National University Hospital(SNUH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 24, 2016

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share