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Nateglinide, a New Mealtime Glucose Regulator

Lack of Pharmacokinetic Interaction with Digoxin in Healthy Volunteers

  • Pharmacokinetics
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Abstract

Objective: To investigate any possible pharmacokinetic interactions that may occur following the coadministration of nateglinide, a new mealtime glucose 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 volunteers aged 19 to 36 years.

Methods: During treatment period 1, all study participants received nateglinide 120mg three times daily for 1 day. They were then randomised to two treatment sequences (n = 6 in each group) in periods 2 and 3, during which they received either a single dose of digoxin 1mg or the combination of nateglinide 120mg three times daily for 2 days plus a single dose of digoxin 1mg on the first day. Blood samples were collected and pharmacokinetic parameters derived. Safety variables measured included ECG parameters and blood pressure.

Results: The concurrent administration of nateglinide and digoxin did not affect the pharmacokinetics of either drug. On the basis of cardiac and haemodynamic assessments, there was no evidence of pharmacodynamic interaction between digoxin and nateglinide. During the study, nateglinide was well tolerated and there were no serious adverse events or drug-related discontinuations in volunteers receiving nateglinide alone or in combination with digoxin.

Conclusion: No adjustment of the dosage of either digoxin or nateglinide is necessary when the drugs are coadministered.

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Acknowledgements

The authors wish to thank Dr Antoine Tarral of Hôpital Stell in France for his expert medical assistance, as well as Franklin Sun for the statistical analysis. This study is sponsored by Novartis Pharmaceuticals Corporation.

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Authors and Affiliations

  1. Clinical Pharmacology Department, Novartis Pharmaceuticals Corporation, 59 Route 10, East Hanover, New Jersey, 07936, USA

    Honghui Zhou, Yulia H. Walter, Damayanthi Devineni &  James F. McLeod

  2. Bioanalytics and Pharmacokinetics Department, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

    Harold Smith

Authors
  1. Honghui Zhou
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  2. Yulia H. Walter
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  3. Harold Smith
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  4. Damayanthi Devineni
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  5. James F. McLeod
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Corresponding author

Correspondence to James F. McLeod.

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Zhou, H., Walter, Y.H., Smith, H. et al. Nateglinide, a New Mealtime Glucose Regulator. Clin. Drug Investig. 19, 465–471 (2000). https://doi.org/10.2165/00044011-200019060-00009

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  • DOI: https://doi.org/10.2165/00044011-200019060-00009

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