NCT02494349
Completed
Phase 1
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.
Overview
- Phase
- Phase 1
- Intervention
- JLP-1207
- Conditions
- LUTS(Lower Urinary Tract Symptoms)
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 54
- Primary Endpoint
- AUClast, Cmax
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
A randomized, open-label, single dose, two-way crossover study.
Investigators
Eligibility 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.
Arms & Interventions
JLP-1207
JLP-1207 dosing in the fed state(high fat meal)
Intervention: JLP-1207
Solifenacin 5mg+Tamsulosin 0.2mg
Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)
Intervention: Solifenacin 5mg+Tamsulosin 0.2mg
Outcomes
Primary Outcomes
AUClast, Cmax
Time Frame: 192 hours
Secondary Outcomes
- AUCinf(192 hours)
- Vd/f(192 hours)
- Tmax(192 hours)
- t1/2(192 hours)
- CL/F(192 hours)
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