Journal of Bioequivalence & Bioavailability

Raghu Naidu

Publications

• Research Article
  A Bioequivalence Study of Nicotine 2 Mg Lozenges in Indian Healthy Adult Human Male Smoker Subjects
  Author(s): Muneesh Garg, Krishnan Iyer, Raghu Naidu and Ratnakar JadhavMuneesh 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, 2‑sequence, 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 refere.. View More»
  DOI: 10.4172/jbb.1000255

  Abstract PDF