NCT02494349CompletedPhase 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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 54
- Primary Endpoint
- AUClast, Cmax
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
JLP-1207
Experimental
JLP-1207 dosing in the fed state(high fat meal)
Intervention: JLP-1207 (Drug)
Solifenacin 5mg+Tamsulosin 0.2mg
Experimental
Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)
Intervention: Solifenacin 5mg+Tamsulosin 0.2mg (Drug)
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)
Investigators
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