Single-Dose Bioequivalence of Two Mini Nicotine Lozenge Formulations

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Abstract

Diverse nicotine replacement therapy options may improve consumer usage. This study was conducted to establish the bioequivalence of a new cherry-flavored mini lozenge with that of a currently marketed mint-flavored mini lozenge. The rate (Cmax) and extent (AUC0–t) of plasma nicotine absorption were compared after administration of 2- and 4-mg doses of each lozenge in healthy adult smokers (n = 43). The bioequivalence of each respective dose was established based on the 90% confidence interval for the ratio of geometric means for both Cmax and AUC0–t lying within the range of 0.80 to 1.25. Adverse-event profiles were similar between formulations.

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