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PK parameters of nicotine in plasma at steady state after 12 hourly doses† of 2 mg lozenge or 4 mg gum (mean ± SD; n = 31) |
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| Formulation\PK parameter |
Nicotinell® lozenge |
Nicorette® gum |
90% CI (lozenge/gum)‡ |
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| 2 mg |
4 mg |
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| Cmax (ng/ml) |
22.5 ± 7.0 |
30.5 ± 12.8 |
0.69–0.89 (F = 0.78) |
| tmax (h) Median [range] |
0.5 [0.25–1.02] |
0.5 [0.25–1.00] |
NS (Friedman ANOVA) |
| AUC11–12 (h·ng/ml) |
20.2 ± 6.8 |
27.5 ± 11.4 |
0.68–0.88 (F = 0.77) |
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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. | |||
Dautzenberg et al. BMC Clinical Pharmacology 2007 7:11 doi:10.1186/1472-6904-7-11 |
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