The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.

Overview

The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.

Full Title of Study: “Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2015

Detailed Description

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

Interventions

  • Drug: JLP-1207
    • The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.
  • Drug: Solifenacin 5mg+Tamsulosin 0.2mg
    • The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.

Arms, Groups and Cohorts

  • Experimental: JLP-1207
    • JLP-1207 dosing in the fed state(high fat meal)
  • Experimental: Solifenacin 5mg+Tamsulosin 0.2mg
    • Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)

Clinical Trial Outcome Measures

Primary Measures

  • AUClast, Cmax
    • Time Frame: 192 hours

Secondary Measures

  • AUCinf
    • Time Frame: 192 hours
  • Tmax
    • Time Frame: 192 hours
  • t1/2
    • Time Frame: 192 hours
  • CL/F
    • Time Frame: 192 hours
  • Vd/f
    • Time Frame: 192 hours

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jeil Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kyung-sang Yu, M.D., Ph.D., Principal Investigator, Seoul National University Hospital(SNUH)

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