Overactive Bladder Clinical Trial
Official title:
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers
Verified date | July 2014 |
Source | Jeil Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
Status | Completed |
Enrollment | 36 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital(SNUH) | Seoul | Jongno-Gu |
Lead Sponsor | Collaborator |
---|---|
Jeil Pharmaceutical Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUCt,ss, Cmax,ss | 192h | No | |
Secondary | C trough,ss | 192h | No | |
Secondary | Tmax,ss | 192h | No | |
Secondary | t1/2 | 192h | No | |
Secondary | CL/F | 192h | No |
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