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A Bioequivalence Study of Nicotine 2 Mg Lozenges in Indian Healthy Adult Human Male Smoker Subjects
Muneesh Garg, Krishnan Iyer, Raghu Naidu and Ratnakar Jadhav
Nicotine Lozenges are used to aid smokers wishing to quit or reduce prior to quitting. The aim of this study was to determine the bioequivalence of a test and reference formulation of Nicotine 2 mg Lozenge. This single dose, randomized, 2-period, 2âsequence, laboratory-blinded, crossover design study was conducted in 28 healthy adult Indian male subjects under fasting conditions with a washout period of 7 days. Study formulations were administered after a 10-hour overnight fast. Blood samples for pharmacokinetic profiling were taken post-dose up to 16 hours. Safety was evaluated through the assessment of adverse events, and laboratory tests. Plasma concentration of Nicotine was determined with a validated LC-MS/MS method. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% CI) for the ratio of AUC0-t and Cmax values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals of Nicotine were 96.16-119.10 and 92.16-111.51 respectively. Since the 90% confidence intervals for Cmax and AUC0-t were within the 80 – 125% interval, it was concluded that the two formulations of Nicotine 2 mg Lozenge are bioequivalent in their rate and extent of absorption.