Formulation\PK parameter | Nicotinell® lozenge | Nicorette® gum | 90% CI (lozenge/gum)#
|
|---|
| | 1 mg | 2 mg‡
| |
|---|
C
max
(ng/ml)
| 10.6 ± 2.9 | 11.4 ± 3.8 | 0.86–1.04 |
C
min
(ng/ml)
| 8.1 ± 2.4 | 9.3 ± 3.4 | ND |
t
max
(h) [range] | 0.54 ± 0.21 [0.00–0.77] | 0.47 ± 0.19 [0.20–0.95] | ND |
t
1/2
(h)
| 3.6 ± 1.2 | 3.2 ± 0.9 | ND |
AUC
11–12
(h·ng/ml)
| 9.2 ± 2.6 | 10.2 ± 3.4 | 0.84–1.01 |
- Initial nicotine concentrations in plasma were 1.1 ng/ml (range: 0.0–6.5) with lozenge and 0.9 ng/ml (0.0–5.1) with gum, reflecting volunteers' heavy smoking habits (≥ 20 cigarettes per day). Correction for initial nicotine concentrations did not modify the results and thus was not retained. ND: not determined.
- †: PK parameters were determined from blood samples drawn after dose 12 (t = 11 h) until t = 23 h.
- ‡: a dose adjustment of the raw data was done for a last standard dose of 1 mg nicotine delivery from the gum.
- #: Standard 90% CI for the expected mean ratio was derived from ANOVA for continuous parameters and compared to standard BAR [0.80–1.25].
