Journal of Bioequivalence & Bioavailability

A bioequivalence study of two Nicotine 2mg Lozenge formulations in healthy adult Indian human male smoker subjects

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Muneesh Garg, Krishnan Iyer, Raghu Naidu and Ratnakar Jadhav

Scientific Tracks Abstracts: J Bioequiv Availab

Abstract:

Nicotine Lozenges are used to aid smokers wishing to quit smoking 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 21 healthy adult Indian human male smoker
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 Cmax and
AUC0-t values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals of Cmax and
AUC0-t for 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.

Biography :

Muneesh Garg has completed his MD Physician from DSMI, Russia and MD Pharmacology from BFUHS Faridkot, Punjab, India. He is the Principal Investigator of Sitec
Labs Pvt. Ltd., Navi Mumbai, India, a premier contract research organization.