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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02180997

Enrollment

Registered

2014-07-03

Start date

2014-07-31

Completion date

2015-03-31

Last updated

2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, LUTS, Overactive Bladder

Keywords

α1-blockers, antimuscarinic agent

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

Interventions

DRUGTamsulosin

Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily

DRUGSolifenacin

Tamsulosin and solifenacin: Solifenacin 10 mg, once daily

DRUGTamsulosin and solifenacin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUCτ,ss, Cmax,ss	192h

Secondary

Measure	Time frame
C trough,ss	192h
Tmax,ss	192h
t1/2	192h
CL/F	192h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026