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.
Keywords: nicotine replacement therapy; nicotinic agonist; smoking; smoking cessation; tobacco; tobacco use cessation products.
© 2017, The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.