Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®)

Table 4 Steady state^† plasma nicotine PK parameters after intake of 1 or 2 mg lozenges to determine dose-concentration proportionality (mean ± SD; n = 31)

Formulation\PK parameter	Nicotinell^® lozenge 1 mg		Nicotinell^® lozenge	90% CI (2 mg/1 mg)^#
	observed	adj. to 2 mg^‡	2 mg
C _max (ng/ml)	11.0 ± 4.9	22.0 ± 9.8	22.5 ± 7.0	0.97–1.19 (F = 1.07)
t _max (h) Median [range]	0.5 [0.25–1.00]	-	0.5 [0.25–1.02]	NS (Friedman ANOVA)
AUC _11–12 (h·ng/ml)	9.7 ± 3.9	19.3 ± 7.8	20.2 ± 6.8	0.98–1.20 (F = 1.08)

NS: not significant.
†: PK parameters were determined from blood samples drawn after dose 12 (t = 11 h) until t = 23 h.
‡: Experimental values (plasma nicotine concentrations) observed with 1 mg lozenge were adjusted to a hypothetical 2 mg dose before calculation of PK parameters.
#: Standard 90% CI for the expected mean ratio was derived from ANOVA for continuous parameters and compared to standard BAR [0.80–1.25]. F: relative bioavailability ratio.