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Raghu Naidu
Raghu Naidu
India
Publications
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Research Article
Bioequivalence Study of Nicotine 4 Mg Lozenges in Indian Healthy Adult Human Male Smoker Subjects
Author(s): Muneesh Garg, Raghu Naidu, Krishnan Iyer and Ratnakar JadhavMuneesh 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 an.. View More»
DOI: 10.4172/jbb.1000265