Table 1 Baseline adjusted nicotine pharmacokinetic parameter outcomes for the four study products. Values in milligrams (mg) refer to pouch nicotine content.
Assessment (unit) | zoneX #5 14 mg (slim) | zoneX #5 16 mg (regular) | zoneX #6 20 mg (regular) | Skruf snus 16.6 mg (slim) | |
---|---|---|---|---|---|
n subjects | 27 | 26 | 26 | 27 | |
Cmax (ng/ml) | Mean (SD) | 14.98 (4.956) | 13.43 (4.967) | 19.35 (6.576) | 13.85 (3.853) |
Median (Min, Max) | 13.94 (6.43, 27.2) | 12.63 (5.63, 28.1) | 17.48 (11.2, 36.5) | 14.05 (7.22, 26.1) | |
Tmax (minutes) | Mean (SD) | 21.66 (5.89) | 22.68 (9.18) | 24.24 (14.76) | 27.78 (19.32) |
Median (Min, Max) | 25.02 (5.00, 30.00) | 25.02 (5.00, 45.00) | 25.02 (5.00, 90.00) | 25.02 (5.00, 90.00) | |
AUCt (h*ng/ml) | Mean (SD) | 36.48 (12.72) | 31.72 (9.500) | 48.44 (19.68) | 32.11 (9.458) |
Median (Min, Max) | 34.83 (22.1, 78.3) | 30.81 (17.3, 61.0) | 43.43 (30.6, 122) | 31.96 (19.7, 64.4) | |
AUC0-90min (h*ng/ml) | Mean (SD) | 14.77 (4.110) | 13.09 (3.915) | 19.82 (6.314) | 13.27 (3.177) |
Median (Min, Max) | 14.74 (7.85, 23.6) | 13.01 (6.56, 22.0) | 17.85 (11.6, 36.2) | 12.47 (8.01, 21.2) | |
AUC0-inf (h*ng/ml) | Mean (SD) | 41.64 (15.88) | 39.97 (26.92) | 55.92 (25.64) | 38.32 (19.50) |
Median (Min, Max) | 38.32 (25.2, 89.4) | 34.39 (19.1, 164) | 50.30 (33.5, 137) | 35.76 (21.9, 123) | |
Clast (ng/ml) | Mean (SD) | 1.285 (0.8236) | 1.290 (1.123) | 1.724 (1.223) | 1.142 (0.8650) |
Median (Min, Max) | 1.036 (0.591, 4.41) | 1.046 (0.500, 6.35) | 1.305 (0.606, 6.44) | 0.9067 (0.530, 5.03) | |
T½(z) (h) | Mean (SD) | 2.585 (0.6147) | 2.934 (1.840) | 2.625 (0.7881) | 2.752 (1.553) |
Median (Min, Max) | 2.452 (1.73, 4.01) | 2.393 (1.60, 11.3) | 2.381 (1.65, 5.35) | 2.450 (1.52, 10.0) |