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

Journal of Clinical Pharmacology
Nova SilverMark Harnett

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 ex...Continue Reading

References

Jun 18, 2003·World Journal of Urology·W F StewartA J Wein
Nov 19, 2003·Current Urology Reports·Raymond W PakDavid R Staskin
May 6, 2004·The Journal of Urology·Norman ZinnerUNKNOWN Trospium Study Group
Nov 2, 2004·International Journal of Clinical Pharmacology and Therapeutics·S SchröderU Fuhr
Jan 9, 2008·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Ulka B CampbellRich Barron
Oct 25, 2008·Current Urology Reports·Scott MacDiarmidBimal K Malhotra

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Citations

Sep 18, 2010·International Journal of Clinical Practice·C Chapple
Aug 9, 2012·Expert Opinion on Drug Metabolism & Toxicology·Umberto Leone Roberti MaggioreSimone Ferrero
Aug 31, 2010·Trends in Pharmacological Sciences·Ariana L Smith, Alan J Wein
Jan 2, 2018·Journal of Managed Care & Specialty Pharmacy·Ali B GoodsonBrian C Lund

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