A Phase 1 interventional study of JLP-1207 and Solifenacin 5mg+Tamsulosin 0.2mg in LUTS(Lower Urinary Tract Symptoms), Benign Prostatic Hyperplasia and Overactive Bladder, sponsored by Jeil Pharmaceutical Co., Ltd.. Completed. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-24.
Sponsored by Jeil Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
A randomized, open-label, single dose, two-way crossover study.
411 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 54 is below the median of 96 across 262 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
JLP-1207 dosing in the fed state(high fat meal)
Drug: JLP-1207
Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)
Drug: Solifenacin 5mg+Tamsulosin 0.2mg
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 page: Solifenacin
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.
AUClast, Cmax
Time frame: 192 hours
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Solifenacin
Lower Urinary Tract Symptoms →
Jeil Pharmaceutical Co., Ltd. →