Table 2 Statistical comparisons for the baseline adjusted nicotine pharmacokinetic (PK) parameters. Values in milligrams (mg) refer to pouch nicotine content.
PK variable | Test product (mg) | Reference product | 95% CI lower bound | Ratio of geometric LS means | 95% CI upper bound | Tukey–Kramer adjusted p value |
---|---|---|---|---|---|---|
Cmax (ng/ml) | #5 14 | Skruf | 0.89 | 1.06 | 1.25 | 0.828 |
#5 14 | #5 16 mg | 0.93 | 1.10 | 1.30 | 0.469 | |
#5 14 | #6 20 mg | 0.66 | 0.78 | 0.93 | 0.002* | |
#5 16 | Skruf | 0.81 | 0.96 | 1.14 | 0.931 | |
#5 16 | #6 20 mg | 0.60 | 0.71 | 0.84 | < 0.0001* | |
#6 20 | Skruf | 1.14 | 1.35 | 1.60 | < 0.0001* | |
AUCt (h*ng/ml) | #5 14 | Skruf | 0.98 | 1.10 | 1.24 | 0.145 |
#5 14 | #5 16 mg | 0.98 | 1.10 | 1.24 | 0.146 | |
#5 14 | #6 20 mg | 0.68 | 0.76 | 0.86 | < 0.0001* | |
#5 16 | Skruf | 0.89 | 1.00 | 1.13 | 1.000 | |
#5 16 | #6 20 mg | 0.61 | 0.69 | 0.78 | < 0.0001* | |
#6 20 | Skruf | 1.28 | 1.45 | 1.63 | < 0.0001* | |
AUC0-inf (h*ng/ml) | #5 14 | Skruf | 0.98 | 1.10 | 1.23 | 0.159 |
#5 14 | #5 16 mg | 0.97 | 1.09 | 1.22 | 0.233 | |
#5 14 | #6 20 mg | 0.68 | 0.77 | 0.86 | < 0.0001* | |
#5 16 | Skruf | 0.90 | 1.01 | 1.13 | 0.997 | |
#5 16 | #6 20 mg | 0.63 | 0.71 | 0.79 | < 0.0001* | |
#6 20 | Skruf | 1.27 | 1.43 | 1.60 | < 0.0001* |