Journal of Bioequivalence & Bioavailability

Raghu Naidu

Publications

• Research Article
  Bioequivalence of Two Different Nicotine Chewing Gum Formulations of Two Different Strengths (2 mg and 4 mg) 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 Mint Flavored Chewing Gums are used to aid smokers wishing to quit or reduce prior to quitting. The aim of these two studies was to determine the bioequivalence of two test and two reference formulations of Nicotine 2 mg and 4 mg Mint Flavored Chewing Gum. Both of these two studies were single dose, randomized, 2-period, 2‑sequence, laboratory-blinded, crossover design conducted in two different set of 54 healthy adult Indian male subjects each under fasting conditions with a washout period of 8 days (for 2 mg study) and 9 days (for 4 mg study). Study formulations were administered after a 10-hour overnight fast. Blood samples for pharmacokinetic profiling were taken post-dose up to 24 hours. Safety was evaluated through the assessment of adverse events, and laboratory tests. Plasma concentrations of Nicotine were determined with a validated LC-.. View More»
  DOI: 10.4172/jbb.1000271

  Abstract PDF