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Predictive Power of an In Vitro System to Assess Drug Interactions of an Antimuscarinic Medication: A Comparison of In Vitro and In Vivo Drug-Drug Interaction Studies of Trospium Chloride With Digoxin

From Indevus Pharmaceuticals Inc, Lexington, Massachusetts (Dr Sandage, Ms Sabounjian, Dr Shipley, Dr Profy, Mr Harnett); SFBC International Inc, Miami, Florida (Dr Lasseter); and BD Biosciences Discovery Labware, Woburn, Massachusetts (Ms Fox).

The authors studied a potential drug-drug interaction via findings from in vitro and in vivo studies, to assess whether the in vitro system was predictive of in vivo clinical pharmacokinetic outcomes. An in vitro experiment and a clinical study were performed to assess the potential for interaction. The effect of trospium chloride on human P-glycoprotein-mediated transport of [³H]-digoxin was determined in vitro. A randomized, crossover clinical trial in 40 subjects was performed to evaluate the effect of trospium on the pharmacokinetics of digoxin in vivo. The findings from the studies were then compared. The in vitro findings in this study were corroborated by the clinical study via assessment of inhibition and impact on pharmacokinetic parameters. The in vitro system for assessment of a potential interaction of 2 drugs excreted primarily through the kidney was predictive of the pharmacokinetic outcomes obtained from a clinical setting.

Key Words: Trospium chloride • digoxin • interaction • clinical trial

Address for reprints: B. Sandage, PhD, Indevus Pharmaceuticals Inc, 33 Hayden Avenue, Lexington, MA 02421; e-mail: bsandage{at}indevus.com.

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