Skip to main content
OpenTrials
Completed

NCT Number: NCT02180997

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

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

Tamsulosin

Drug

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

Other names: Harnal-D tablet

solifenacin

Drug

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

Other names: Vesicare tablet

Tamsulosin and solifenacin

Drug

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily

Other names: Harnal-D and Vesicare tablet

Primary outcomes

  1. AUCτ,ss, Cmax,ss

    Time frame: 192h

Secondary outcomes

  1. C trough,ss

    Time frame: 192h

  2. Tmax,ss

    Time frame: 192h

  3. t1/2

    Time frame: 192h

  4. CL/F

    Time frame: 192h

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2014
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.

Published trials that share one or more normalized conditions with this study.