PC Concentrations

This is an example of a study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches. Three different nicotine pouches were used in the study. Each pouch was evaluated in 180 minute test session. AUC and CMAX were to be determined.    

The study consisted of a screening period, one day of admission, four separate days of on-site product use with 1–3 days in between each product use, and a 7-day safety follow-up period

45, 30, and 15 minutes prior start of product use and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after start of product use.

(C_max), time to reach C_max (t_max), and the baseline-corrected area under the plasma concentration–time curves (i) from start of product use (t₀) to the last quantifiable nicotine concentration time point (AUC_0-last) and (ii) from t₀ to 10 minutes after t₀ (AUC_0-10’). The pharmacokinetic parameters were derived from plasma nicotine concentrations-versus-time data by means of non-compartmental analysis using Phoenix WinNonlin (version 6.2, Pharsight Corp, Sunnyvale, California) and corrected for baseline following the method described by Kraiczi et al.³⁰ whereby the baseline (C₀) was defined as the average concentration of the three time points prior to t₀ (45, 30, and 15 minutes prior to t₀) of each visit from whose slope the elimination rate constant (k) was estimated and then used for the calculation of the baseline corrected values.