Single‐Dose Bioequivalence of Two Mini Nicotine Lozenge Formulations
Submitted by Jose Luis Vazquez Martinez
- 19 April 2018
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.