NDLI: Pharmacokinetics of once-daily trospium chloride 60 mg extended release and twice-daily trospium chloride 20 mg in healthy adults.

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Pharmacokinetics of once-daily trospium chloride 60 mg extended release and twice-daily trospium chloride 20 mg in healthy adults.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Silver, Nova Sandage, Bobby Sabounjian, LuAnn Schwiderski, Ute Shipley, James Harnett, Mark
Description	Country affiliation: United States Author Affiliation: Silver N ( Endo Pharmaceuticals, Inc, Lexington, MA 02421, USA. silver.nova@endo.com)
Abstract	The objective of this study is to characterize the steady-state pharmacokinetics and compare the relative bioavailability of the extended-release capsule formulation of the antimuscarinic trospium chloride, developed for once-daily administration, and trospium chloride immediate-release tablets. This is a single-center, multidose, randomized, open-label, 2-period, 2-arm crossover, bioavailability study in healthy adult male and female subjects who are within 20% of their ideal body weight. Subjects receive trospium 60-mg extended-release capsules once daily and trospium 20-mg tablets twice daily for 10 days, each in a crossover manner. Twenty-four subjects are enrolled in the study. With multiple dosing of trospium 60 mg extended-release once daily versus 20 mg twice daily, lower geometric least squares mean area under the concentration-time curve from 0 to 24 hours (17 360 vs 28 590 pg.h/mL; ratio 61%; 90% confidence interval, 51-72) and maximum plasma concentration (1517 vs 2502 pg/mL; 61%; 90% confidence interval, 49-75) are observed. Furthermore, with trospium 60 mg extended-release versus 20 mg, median time to maximum plasma concentration is later (5.0 vs 4.5 hours) and half-life is longer (35.8 vs 27.2 hours). Trospium exposure is lower with multiple dosing of trospium 60 mg extended-release compared with trospium 20 mg twice daily. Thus, with the extended-release formulation, trospium concentrations are less likely to reach the threshold where adverse events may sometimes occur.
File Format	HTM / HTML
ISSN	00912700
Issue Number	2
Volume Number	50
e-ISSN	15524604
Journal	The Journal of Clinical Pharmacology
Language	English
Publisher	Wiley
Publisher Date	2010-02-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Nortropanes Pharmacokinetics Adolescent Adult Benzilates Biological Availability Capsules Cross-over Studies Delayed-action Preparations Drug Administration Schedule Female Humans Male Middle Aged Administration & Dosage Parasympatholytics Tablets Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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