Nateglinide, a new mealtime glucose regulator - Lack of pharmacokinetic interaction with digoxin in healthy volunteers

Objective: To investigate any possible pharmacokinetic interactions that ma y occur following the coadministration of nateglinide, a new mealtime gluco se regulator, and digoxin. Design and Setting: This was a partially randomised, three-period, nonblind , crossover study performed at a single centre in healthy male and female v olunteers aged 19 to 36 years. Methods: During treatment period 1, all study participants received nategli nide 120mg three times daily for 1 day. They were then randomised to two tr eatment sequences (n = 6 in each group) in periods 2 and 3, during which th ey received either a single dose of digoxin I mg or the combination of nate glinide 120mg three times daily for 2 days plus a single dose of digoxin 1m g on the first day. Blood samples were collected and pharmacokinetic parame ters derived. Safety variables measured included ECG parameters and blood p ressure. Results: The concurrent administration of nateglinide and digoxin did not a ffect the pharmacokinetics of either drug. On the basis of cardiac and haem odynamic assessments, there was no evidence of pharmacodynamic interaction between digoxin and nateglinide. During the study, nateglinide was well tol erated and there were no serious adverse events or drug-related discontinua tions in volunteers receiving nateglinide alone or in combination with digo xin. Conclusion: No adjustment of the dosage of either digoxin or nateglinide is necessary when the drugs are coadministered.