Overview

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

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Treatments:
Solifenacin Succinate
Tamsulosin
Criteria
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.