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Effect of age and gender on the pharmacokinetics of solifenacin
Author(s) -
Smulders R.,
Taekema M.,
Krauwinkel W.,
Raghoebar M.
Publication year - 2005
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2004.12.170
Subject(s) - solifenacin , cmax , pharmacokinetics , medicine , crossover study , overactive bladder , muscarinic antagonist , urinary incontinence , antagonist , urology , endocrinology , placebo , receptor , alternative medicine , pathology
Background Overactive bladder (OAB) is a syndrome consisting of urinary frequency and urgency, with or without urge incontinence. Solifenacin is a new muscarinic receptor antagonist for the treatment of OAB. This trial was designed to study the effect of age and gender on the steady state pharmacokinetics (PK) of solifenacin at two dose levels. Methods 47 healthy subjects [24 young (aged 35 (20–55)); 23 elderly (68 (64–78)); 12 males in each age group] were enrolled in an open‐label, crossover trial. Solifenacin 5 or 10 mg was administered, once daily, during two 14‐day study periods separated by a washout period. PK variables were C max , AUC 0–24h , t ½ , and t max . Results A dose‐proportional increase was observed for C max and AUC 0–24h in young and elderly subjects. In elderly subjects C max and AUC 0–24h were 16% (90% CI 0.973–1.373) and 20% (1.003–1.435) higher, resp., compared to young subjects. Mean t max and t ½ were slightly higher in elderly subjects versus young subjects. Values for C max and AUC 0–24h were equivalent between males and females[0.947 (0.796–1.127) and 0.977 (0.815–1.172) resp.]. Mean t max was comparable in men and women; there was a tendency towards a shorter t 1/2 in women. Mean t max and t 1/2 remained unaffected when increasing the dose from 5 to 10 mg. Conclusions Slight differences in PK of solifenacin were observed between young and elderly, and male and female subjects. However, these were considered not clinically relevant and no dose adjustment based on age or gender is recommended. Clinical Pharmacology & Therapeutics (2005) 77 , P73–P73; doi: 10.1016/j.clpt.2004.12.170