Assessment of the Potential Pharmacokinetic Interaction Between Digoxin and Ethmozine

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Abstract
The potential for a pharmacokinetic interaction between the investigational antiarrhythmic drug ethmozine (moricizine HCl, the generic name that is infrequently used in existing literature) and digoxin was evaluated in nine healthy male adults. Serum and urinary digoxin concentrations were measured by radioimmunoassay following intravenous digoxin administration before and during steady‐state ethmozine dosing. Plasma ethmozine levels following a single oral dose were measured before and after a single intravenous dose of digoxin. A mean elimination half‐life of 45.6 hours was determined for digoxin alone, compared to 43.1 hours in combination with ethmozine. Average values for digoxin systemic clearance, apparent volume of distribution, and renal clearance were 2.87 mL/min/kg, 11.3 L/kg, and 2.44 mL/min/kg, respectively for digoxin alone, compared to 3.01 mL/min/kg, 11.3 L/kg, and 2.64 mL/min/kg, respectively for digoxin with ethmozine. A mean half‐life of 2.0 hours was determined for ethmozine alone, compared with 1.8 hours following a single intravenous dose of digoxin. No change was observed in the oral pharmacokinetics of ethmozine following a single intravenous dose of digoxin, as indicated by the area under the plasma concentration versus time curve, Cmax or Tmax. These findings suggest that no pharmacokinetic interaction occurs when single intravenous doses of digoxin are co‐administered with multiple oral doses of ethmozine.