Bioequivalence Study of Nicotine 4 Mg Lozenges in Indian Healthy Adult Human Male Smoker Subjects
Muneesh Garg*, Raghu Naidu, Krishnan Iyer and Ratnakar Jadhav
Sitec Labs Pvt. Ltd., PEE-DEE Infotech, Plot No. Gen-40, TTC MIDC, Near Nelco, Behind Millennium Business Park, Mahape, Navi Mumbai, India
- *Corresponding Author:
- Muneesh Garg
Sitec Labs Pvt. Ltd., PEE-DEE Infotech
Plot No. Gen-40, TTC MIDC
Near Nelco, Behind Millennium Business Park
Mahape, Navi Mumbai, India
Fax: 91222778 6241
E-mail: [email protected]
Received Date: November 26, 2015 Accepted Date: December 23, 2015 Published Date: December 30, 2015
Citation: Garg M, Naidu R, Iyer K, Jadhav R (2016) Bioequivalence Study of Nicotine 4 Mg Lozenges in Indian Healthy Adult Human Male Smoker Subjects. J Bioequiv Availab 8: 044-048. doi: 10.4172/jbb.1000265
Copyright: © 2016 Garg M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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, 2Ã¢ÂÂsequence, 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.