生物等效性和生物利用度杂志

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Bioequivalence Study of Nicotine 4 Mg Lozenges in Indian Healthy Adult Human Male Smoker Subjects

Muneesh Garg, Raghu Naidu, Krishnan Iyer 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 4 mg Lozenge. This single dose, randomized, 2-period, 2‑sequence, laboratory-blinded, crossover design study was conducted in 28 Indian healthy adult human male smoker subjects under fasting conditions with a washout period of 7 days. Study formulations were administered after a 10 hrs overnight fast. Blood samples for pharmacokinetic profiling were taken postdose up to 16 hrs. Safety was evaluated through the assessment of adverse events, and laboratory tests. Plasma concentrations of Nicotine were determined with a validated LC-MS/MS method. Bioequivalence between the products was determined by calculating 90% confidence interval (90% CI) for the ratio of Cmax and AUC0-t values for the test and reference products, using logarithmic transformed data. The 90% CI of Nicotine were 109.85-123.32 and 101.48-115.41 for Cmax and AUC0-t respectively. Since the 90% CI for Cmax and AUC0-t were within the 80-125% interval, it was concluded that the two formulations of Nicotine 4 mg Lozenge are bioequivalent in their rate and extent of absorption.