The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.
Overview
The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.
Full Title of Study: “Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2015
Detailed Description
A randomized, open-label, single dose, two-way crossover study.
Interventions
- Drug: JLP-1207
- The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.
- Drug: Solifenacin 5mg+Tamsulosin 0.2mg
- The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.
Arms, Groups and Cohorts
- Experimental: JLP-1207
- JLP-1207 dosing in the fed state(high fat meal)
- Experimental: Solifenacin 5mg+Tamsulosin 0.2mg
- Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)
Clinical Trial Outcome Measures
Primary Measures
- AUClast, Cmax
- Time Frame: 192 hours
Secondary Measures
- AUCinf
- Time Frame: 192 hours
- Tmax
- Time Frame: 192 hours
- t1/2
- Time Frame: 192 hours
- CL/F
- Time Frame: 192 hours
- Vd/f
- Time Frame: 192 hours
Participating in This Clinical Trial
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.
Gender Eligibility: Male
Minimum Age: 19 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Kyung-sang Yu, M.D., Ph.D., Principal Investigator, Seoul National University Hospital(SNUH)
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