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OpenTrials
Completed

NCT Number: NCT02494349

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JLP-1207

Drug

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.

Solifenacin 5mg+Tamsulosin 0.2mg

Drug

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.

Primary outcomes

  1. AUClast, Cmax

    Time frame: 192 hours

Secondary outcomes

  1. AUCinf

    Time frame: 192 hours

  2. Tmax

    Time frame: 192 hours

  3. t1/2

    Time frame: 192 hours

  4. CL/F

    Time frame: 192 hours

  5. Vd/f

    Time frame: 192 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2015
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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