Formulation\PK parameter | Nicotinell® lozenge | Nicorette® gum | 90% CI (lozenge/gum)‡
|
---|
| 2 mg | 4 mg | |
---|
C
max
(ng/ml)
| 22.5 ± 7.0 | 30.5 ± 12.8 | 0.69–0.89 (F = 0.78) |
t
max
(h) Median [range] | 0.5 [0.25–1.02] | 0.5 [0.25–1.00] | NS (Friedman ANOVA) |
AUC
11–12
(h·ng/ml)
| 20.2 ± 6.8 | 27.5 ± 11.4 | 0.68–0.88 (F = 0.77) |
- NS: not significant.
- †: PK parameters were determined from blood samples drawn after dose 12 (t = 11 h) until t = 23 h.
- ‡: Standard 90% CI for the expected mean ratio (test/reference = lozenge/gum) was derived from ANOVA for continuous parameters and compared to standard BAR [0.80–1.25] and enlarged BAR [0.7–1.43]. F: relative bioavailability ratio.