The pharmacokinetic profile of fesoterodine 8 mg with daytime or nighttime dosing

European Journal of Clinical Pharmacology

Volumn 66, Issue 2, 2010, Pages 171-176

  Malhotra, Bimal K ^a   Crownover, Penelope H ^a   Labadie, Robert ^a   Glue, Paul ^b   MacDiarmid, Scott A ^c  

^a PFIZER INC   (United States)

^b UNIVERSITY OF OTAGO   (New Zealand)

^c Alliance Urology Specialists   (United States)

Author keywords

5 HMT; Diurnal; Fesoterodine; Overactive bladder; Pharmacokinetics

Indexed keywords

5 HYDROXYMETHYLTOLTERODINE; DRUG METABOLITE; FESOTERODINE; UNCLASSIFIED DRUG;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CIRCADIAN RHYTHM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; EVENING DOSAGE; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; MORNING DOSAGE; NORMAL HUMAN; PRIORITY JOURNAL; PYURIA; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSTAINED DRUG RELEASE; TIME TO MAXIMUM PLASMA CONCENTRATION; VAGINA CANDIDIASIS;

ADOLESCENT; ADULT; BENZHYDRYL COMPOUNDS; BIOLOGICAL AVAILABILITY; BODY MASS INDEX; CRESOLS; CROSS-OVER STUDIES; CYTOCHROME P-450 CYP2D6; DELAYED-ACTION PREPARATIONS; DRUG CHRONOTHERAPY; FEMALE; GENOTYPE; HALF-LIFE; HEADACHE; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; STATISTICS AS TOPIC; YOUNG ADULT;

EID: 76949103010     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-009-0748-y     Document Type: Article

References (29)

1. P Abrams L Cardozo M Fall, et al. 2003 The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society Urology 61 1 37 49 10.1016/S0090- 4295(02)02243-4 12559262 (Pubitemid 36151708)
2. P Abrams W Artibani L Cardozo, et al. 2006 Reviewing the ICS 2002 terminology report: the ongoing debate Neurourol Urodyn 25 293 10.1002/nau.20251
3. I Milsom P Abrams L Cardozo, et al. 2001 How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study Br J Urol Int 87 9 760 766 1:STN:280:DC%2BD3Mzls1OhtA%3D%3D
4. WF Stewart JB Van Rooyen GW Cundiff, et al. 2003 Prevalence and burden of overactive bladder in the United States World J Urol 20 6 327 336 1:STN:280:DC%2BD3s3osVWkuw%3D%3D 12811491
5. LK Carr 2008 Overactive bladder Can J Urol 15 Suppl 1 32 36 18700063 discussion 36
6. C Chapple P Van Kerrebroeck A Tubaro, et al. 2007 Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder Eur Urol 52 4 1204 1212 10.1016/j.eururo.2007.07.009 1:CAS:528:DC%2BD2sXht1Wgu77O 17651893 (Pubitemid 47332062)
7. V Nitti R Dmochowski P Sand, et al. 2007 Efficacy, safety, and tolerability of fesoterodine in subjects with overactive bladder J Urol 178 2488 2494 10.1016/j.juro.2007.08.033 1:CAS:528:DC%2BD2sXhsVelur%2FK 17937959 (Pubitemid 350052177)
8. MC Michel 2008 Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome Expert Opin Pharmacother 9 10 1787 1796 10.1517/14656566.9.10.1787 1:CAS:528:DC%2BD1cXnsFeitL8%3D 18570610
9. A Tubaro C De Nunzio 2004 Comparison of peripherally active substance for treatment of detrusor overactivity: what is new; what is in the pipeline EAU Update Ser 2 4 161 169 10.1016/j.euus.2004.09.001 (Pubitemid 39618954)
10. P Cole 2004 Fesoterodine, an advanced antimuscarinic for the treatment of overactive bladder: a safety update Drugs Future 29 7 715 720 10.1358/dof.2004.029.07.854168 1:CAS:528:DC%2BD2cXoslGgtrY%3D (Pubitemid 39279145)
11. B Malhotra R Sachse N Wood 2009 Influence of food on the pharmacokinetic profile of fesoterodine Int J Clin Pharmacol Ther 47 6 384 390 1:CAS:528:DC%2BD1MXptVegurY%3D 19473600
12. M Baraldo 2008 The influence of circadian rhythms on the kinetics of drugs in humans Expert Opin Drug Metab Toxicol 4 2 175 192 10.1517/17425255.4.2. 175 1:CAS:528:DC%2BD1cXhsVSgurc%3D 18248311 (Pubitemid 351308416)
13. JG Hatlebakk PO Katz B Kuo, et al. 1998 Nocturnal gastric acidity and acid breakthrough on different regimens of omeprazole 40 mg daily Aliment Pharmacol Ther 12 12 1235 1240 10.1046/j.1365-2036.1998.00426.x 1:CAS:528:DyaK1MXlvV2ksA%3D%3D 9882032 (Pubitemid 28565964)
14. ND Pehlivanov M Olyaee I Sarosiek, et al. 2003 Comparison of morning and evening administration of rabeprazole for gastro-oesophageal reflux and nocturnal gastric acid breakthrough in patients with reflux disease: a double-blind, cross-over study Aliment Pharmacol Ther 18 9 883 890 10.1046/j.1365-2036.2003.01776.x 1:CAS:528:DC%2BD3sXpvFSksrc%3D 14616152 (Pubitemid 37346673)
15. SK Gupta G Sathayan 1999 Pharmacokinetics of an oral once-a-day controlled-release oxybutynin formulation compared with immediate-release oxybutynin J Clin Pharmacol 39 289 296 1:CAS:528:DyaK1MXjsVGmtbY%3D 10073329
16. R Rackley JP Weiss ES Rovner, et al. 2006 Nighttime dosing with tolterodine reduces overactive bladder-related nocturnal micturitions in patients with overactive bladder and nocturia Urology 67 4 731 736 10.1016/j.urology.2005.10.061 16618562
17. Center for Drug Evaluation and Research (2007) Clinical Pharmacology and Biopharmaceutics Review application NDA 22-103. Silver Spring, MD
18. K May K Westphal T Giessmann, et al. 2008 Disposition and antimuscarinic effects of the urinary bladder spasmolytics propiverine: influence of dosage forms and circadian-time rhythms J Clin Pharmacol 48 5 570 579 10.1177/0091270008315314 1:CAS:528:DC%2BD1cXlvVGqsb0%3D 18319360
19. S MacDiarmid BW Sandage Jr BK Malhotra 2008 The effects of reformulation: improved therapeutic index Curr Urol Rep 9 6 465 471 10.1007/s11934-008-0080-6 18947511
20. (2003) Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products-general consideration. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville
21. B Olsson J Szamosi 2001 Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine Clin Pharmacokinet 40 3 227 235 10.2165/00003088-200140030-00006 1:CAS:528:DC%2BD3MXjsVWmtrc%3D 11327200 (Pubitemid 32324452)
22. RU Anderson D Mobley B Blank, et al. 1999 Once daily controlled versus immediate release oxybutynin chloride for urge urinary incontinence. OROS Oxybutynin Study Group J Urol 161 6 1809 1812 10.1016/S0022-5347(05)68810-6 1:CAS:528:DyaK1MXjtlyrur8%3D 10332441 (Pubitemid 29420737)
23. P van Kerrebroeck K Kreder U Jonas, et al. 2001 Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder Urology 57 3 414 421 10.1016/S0090-4295(00)01113-4 11248608 (Pubitemid 32192963)
24. E Versi R Appell D Mobley, et al. 2000 Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence. The Ditropan XL Study Group Obstet Gynecol 95 5 718 721 10.1016/S0029-7844(99)00661-4 1:CAS:528:DC%2BD3cXisFGntb4%3D 10775736 (Pubitemid 30210058)
25. KP Junemann E Hessdorfer I Unamba-Oparah, et al. 2006 Propiverine hydrochloride immediate and extended release: comparison of efficacy and tolerability in patients with overactive bladder Urol Int 77 4 334 339 10.1159/000096338 17135784 (Pubitemid 44837003)
26. G Sathyan MB Chancellor SK Gupta 2001 Effect of OROS controlled-release delivery on the pharmacokinetics and pharmacodynamics of oxybutynin chloride Br J Clin Pharmacol 52 4 409 417 10.1046/j.0306-5251.2001.01463.x 1:CAS:528:DC%2BD3MXnvVansL0%3D 11678784 (Pubitemid 32939443)
27. Sanctura (trospium chloride) (2007) Full prescribing information. Allergan, Irvine
28. RR Dmochowski KM Peters JD Morrow, et al. 2009 Randomized, double-blind, placebo-controlled study of flexible-dose fesoterodine in subjects with overactive bladder Neurourol Urodyn 28 2 145 Abstract 165
29. JJ Wyndaele ER Goldfischer JD Morrow, et al. 2009 Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study Int J Clin Pract 63 4 560 567 10.1111/j.1742-1241.2009.02035.x 1:STN:280:DC%2BD1M3mtVShsQ%3D%3D 19348029