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document
Concurrent administration of donepezil HCl and digoxin : assessment of pharmacokinetic changes . AIM The aim of this study was to examine the pharmacokinetics of donepezil HCl and digoxin separately , and in combination , following administration of single oral doses . Changes in cardiac conduction parameters following drug administration were also assessed . METHODS This was an open-label , randomized , three-period crossover study in healthy male volunteers ( n=12 ) . During each treatment period , subjects received a single dose of either donepezil HCl ( 5 mg ) , digoxin ( 0.25 mg ) , or a combination of both drugs . Each treatment period was followed by a 2-week , drug-free washout period . RESULTS All 12 volunteers completed the study without incident . No statistically significant differences in donepezil pharmacokinetics ( Cmax , tmax , AUC ( 0-120 ) , AUC ( 0-infinity ) or t1/2 ) were observed when donepezil administered alone was compared with donepezil administered in combination with digoxin . Similarly , no statistically significant differences in digoxin pharmacokinetics were observed when digoxin was administered alone or in combination with donepezil . No clinically relevant changes in cardiac conduction ( lead II ECG ) were observed in any subject during any treatment period . CONCLUSIONS Co-administration of single doses of donepezil HCl ( 5 mg ) and digoxin ( 0.25 mg ) produced no changes in the pharmacokinetic profile of either drug . In addition , co-administration produced no changes in cardiac conduction parameters during the 24 h of telemetry monitoring following drug administration .
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Intervention_Pharmacological
donepezil HCl and digoxin :
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Intervention_Pharmacological
donepezil HCl and digoxin separately , and in combination
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Intervention_Pharmacological
donepezil HCl ( 5 mg )
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Intervention_Pharmacological
digoxin ( 0.25 mg )
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Intervention_Pharmacological
donepezil administered alone
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Intervention_Pharmacological
donepezil administered
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Intervention_Pharmacological
digoxin
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Intervention_Pharmacological
digoxin
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Outcome_Physical
donepezil pharmacokinetics
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Outcome_Physical
cardiac conduction
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Participant_Sex
male
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Participant_Sample-size
12