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.

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.

Start Date01 Aug 2015

Sponsor / Collaborator

Jeil Pharmaceutical Co., Ltd.

NCT02447367 / CompletedPhase 1

Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Start Date01 Jul 2015

Sponsor / Collaborator

Jeil Pharmaceutical Co., Ltd.

NCT02180997 / CompletedPhase 1

Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

Start Date01 Jul 2014

Sponsor / Collaborator

Jeil Pharmaceutical Co., Ltd.

100 Clinical Results associated with Solifenacin Succinate/Tamsulosin Hydrochloride

100 Translational Medicine associated with Solifenacin Succinate/Tamsulosin Hydrochloride

100 Patents (Medical) associated with Solifenacin Succinate/Tamsulosin Hydrochloride

Literatures (Medical) associated with Solifenacin Succinate/Tamsulosin Hydrochloride

01 Mar 2019·Neurourology and UrodynamicsQ3 · MEDICINE

Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe

Q3 · MEDICINE

Article

Author: Foley, Steve ; De Wachter, Stefan ; Rees, Jonathan ; Walters, Carien ; Rosa Arias, José ; Skoumal, René ; Yavuz, Yalcin ; Huang, Moses

AbstractAimTo evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α‐blocker), on health‐related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice.MethodsEUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB‐q) symptom bother subscale score. Change from baseline in OAB‐q total and coping, sleep, and social interaction subscale scores, treatment satisfaction‐visual analog scale (TS‐VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire were also evaluated.ResultsFive hundred and eighty‐nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB‐q symptom bother subscale scores were −16.40 (−24.31, −8.49) at weeks 4 to 8 and −19.59 (−28.26, −10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS‐VAS, IPSS, and EQ‐5D‐5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients.ConclusionsVesomni was well‐tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.

100 Deals associated with Solifenacin Succinate/Tamsulosin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G04CA53	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	NL	Astellas Pharma, Inc.	07 Oct 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dysuria	Preclinical	GB	Astellas Pharma Europe Ltd.	01 Apr 2010
Urinary Bladder, Overactive	Preclinical	GB	Astellas Pharma Europe Ltd.	01 Apr 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01021332 (Neptune II, CTgov)	Phase 3	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	1,067	tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)	hcfrdgpvgz(xbywlxvvbj) = zedwirgwsk rewyovmctb (fedhibcfgj, ncdzehvueq - dikrzieapj) View more	-	22 Jan 2016
NCT01018511 (Neptune, CTgov)	Phase 3	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	1,334	Placebo tamsulosin hydrochloride OCAS 0.4 mg+Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (Placebo)	souleqikch(ktobeyfjwh) = tdpwznnogw hdtnrpdbhk (odostgyvfi, tkeeefijho - qpwdpcdbzz) View more	-	17 Dec 2015
				tamsulosin hydrochloride OCAS 0.4 mg+Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (TOCAS 0.4 mg)	souleqikch(ktobeyfjwh) = rehbqlxfav hdtnrpdbhk (odostgyvfi, dyedayymze - kmttrzzzlb) View more
NCT01533597 (CTgov)	Phase 4	Urinary Bladder, Overactive	70	Solifenacin (Solifenacin)	lamepqeotg(zjcbfpofwk) = fzewnxgdih pencsrsegn (qjmriddmdy, nlhshhdcme - ihbpliniqm) View more	-	27 Jan 2015
				Solifenacin plus Tamsulosin (Solifenacin Plus Tamsulosin)	lamepqeotg(zjcbfpofwk) = tjyrtfyqam pencsrsegn (qjmriddmdy, ychgrtrnlx - fpseeerihu) View more
AUA2014	Not Applicable	Prostatic Hyperplasia	155	Solifenacin 5 mg/day	(juzmtyksju) = 1 case had blurred vision xjhchxytyn (jmzprtgtvj ) View more	-	01 Apr 2014
				Mirabegron 50 mg/day

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