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Pharmacokinetics of Once‐Daily Trospium Chloride 60 mg Extended Release and Twice‐Daily Trospium Chloride 20 mg in Healthy Adults

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.