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

Phase 1

Completed

• Conditions: LUTS; Benign Prostatic Hyperplasia; Overactive Bladder
• Interventions: Drug: Tamsulosin; Drug: Tamsulosin and solifenacin; Drug: Solifenacin

• Registration Number: NCT02180997
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Solifenacin 2	Tamsulosin and solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Co-administration 2	Tamsulosin	Volunteers will be taken Tamsulosin and solifenacin
Co-administration 2	Solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Tamsulosin 1	Tamsulosin and solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Solifenacin 1	Tamsulosin and solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Tamsulosin 2	Tamsulosin and solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Solifenacin 2	Tamsulosin	Volunteers will be taken Tamsulosin and solifenacin
Tamsulosin 2	Solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Tamsulosin 1	Solifenacin	Volunteers will be taken Tamsulosin and solifenacin
Solifenacin 1	Tamsulosin	Volunteers will be taken Tamsulosin and solifenacin
Co-administration 1	Tamsulosin	Volunteers will be taken Tamsulosin and solifenacin
Co-administration 1	Solifenacin	Volunteers will be taken Tamsulosin and solifenacin

Primary Outcome Measures

Name	Time	Method
AUCτ,ss, Cmax,ss	192h

Secondary Outcome Measures

Name	Time	Method
C trough,ss	192h
CL/F	192h
Tmax,ss	192h
t1/2	192h

Trial Locations

Locations (1)

Seoul National University Hospital(SNUH); 🇰🇷 Seoul, Jongno-Gu, Korea, Republic of