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Multiple-dose pharmacokinetics of intranasally administered IS-159 in healthy subjects

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Summary

This study was designed to investigate the multiple — dose pharmacokinetics of a range of intransal doses of IS-159, a serotonin 1B/1D receptor agonist. Intranasal doses of 1, 2, 4 and 6 mg of IS-159 were administered twice at an interval of 4 hours to 17 healthy male and female subjects in a two-way crossover study. Plasma concentrations of IS-159 were determined from blood samples taken at regular intervals up to 24 hours after the first administration during both treatment periods. IS-159 was rapidly absorbed and eliminated with a tmax of approximately 15 min and a t1/2 of approximately 1.6 hours. With increasing dose, the exposure increased dose-proportionally, and IS-159 pharmacokinetics appear not to be influenced by gender and food intake. The results showed dose-proportional pharmacokinetics of IS-159 in the dose range tested and a low propensity for drug accumulation.

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  1. The Medicines Company, Gasstrasse 1, CH-4056, Basel, Switzerland

    Paul L. M. van Giersbergen & Jasper Dingemanse Ph.D.

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  1. Paul L. M. van Giersbergen
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  2. Jasper Dingemanse Ph.D.
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van Giersbergen, P.L.M., Dingemanse, J. Multiple-dose pharmacokinetics of intranasally administered IS-159 in healthy subjects. Eur. J. Drug Metab. Pharmacokinet. 28, 49–54 (2003). https://doi.org/10.1007/BF03190866

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  • DOI: https://doi.org/10.1007/BF03190866

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