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.