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Steady state† plasma nicotine PK parameters after intake of 1 or 2 mg lozenges to determine dose-concentration proportionality (mean ± SD; n = 31) |
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| Formulation\PK parameter |
Nicotinell® lozenge 1 mg |
Nicotinell® lozenge |
90% CI (2 mg/1 mg)# |
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| observed |
adj. to 2 mg‡ |
2 mg |
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| Cmax (ng/ml) |
11.0 ± 4.9 |
22.0 ± 9.8 |
22.5 ± 7.0 |
0.97–1.19 (F = 1.07) |
| tmax (h) Median [range] |
0.5 [0.25–1.00] |
- |
0.5 [0.25–1.02] |
NS (Friedman ANOVA) |
| AUC11–12 (h·ng/ml) |
9.7 ± 3.9 |
19.3 ± 7.8 |
20.2 ± 6.8 |
0.98–1.20 (F = 1.08) |
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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. ‡: 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. | ||||
Dautzenberg et al. BMC Clinical Pharmacology 2007 7:11 doi:10.1186/1472-6904-7-11 |
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