A Single-Dose, Crossover-Design Bioequivalence Study Comparing Two Nicotine Gum Formulations in Healthy Subjects

Advances in Therapy
Daniel Du

Abstract

Nicotine replacement therapy (NRT) benefits smokers who wish to quit; nicotine gum represents one NRT. New formulations of nicotine gum have been developed to consider consumer preferences and needs. A new mint-flavored nicotine gum with a different texture was developed that may provide a more appealing taste and chewing experience. This study evaluated this new nicotine gum (2 and 4 mg strengths) for bioequivalence versus the original flavor sugar-free nicotine gum at corresponding dosages. All subjects randomized in this crossover study received a single dose of all treatments, i.e., 2 and 4 mg doses of test and reference gums, separated by 2-7 days of washout between treatments. Subjects' maximal plasma nicotine concentration (Cmax) and extent of nicotine absorption (AUC0-t) following the administration of each treatment were calculated from plasma nicotine concentrations. Ratios of test/reference for Cmax and AUC0-t were calculated to evaluate bioequivalence between the two products. Both 2 and 4 mg doses of the new mint-flavored nicotine gum were bioequivalent to the dose-matched reference product as determined by the ratio of the geometric means and their 90% confidence intervals for Cmax and AUC0-t as well as secondary ...Continue Reading

References

May 1, 1991·British Journal of Addiction·K O Fagerström
Dec 13, 2005·Clinical Pharmacology and Therapeutics·Anil BatraTobias Danielsson
Jan 13, 2009·American Journal of Preventive Medicine·Saul ShiffmanKenneth R Strahs
Feb 3, 2009·Handbook of Experimental Pharmacology·Neal L BenowitzPeyton Jacob
Dec 2, 2017·Clinical Pharmacology in Drug Development·Scott C RasmussenGilbert M Shanga
Jan 20, 2018·International Journal of Clinical Pharmacology and Therapeutics·Manpreet SukhijaAditya Kaushik

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Methods Mentioned

BETA
contraception
pregnancy test

Clinical Trials Mentioned

NCT01847443

Software Mentioned

Phoenix Win - Nonlin

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