Figure 1.
Statistical comparisons of nicotine pharmacokinetic parameters_
| Comparison | p value | |||
|---|---|---|---|---|
| Reference product | Comparator product | Cmax | AUCnic 0–180 | Tmax |
| Velo Max Wintergreen 7-mg | Velo Wintergreen 4-mg | < 0.0001 1 | < 0.0001 1 | 0.63 |
| Velo Max Wintergreen 7-mg | Velo Max Spearmint 7-mg | 0.19 | 0.13 | 0.99 |
| Velo Max Wintergreen 7-mg | Velo Max Peppermint 7-mg | 0.19 | 0.12 | 0.26 |
| Velo Max Wintergreen 7-mg | Velo Max Citrus Burst 7-mg | 0.67 | 0.45 | 0.65 |
| Velo Max Wintergreen 7-mg | Velo Max Black Cherry 7-mg | 0.10 | 0.10 | 0.36 |
| Velo Max Wintergreen 7-mg | Velo Max Coffee 7-mg | 0.83 | 0.35 | 0.50 |
| Velo Max Wintergreen 7-mg | Velo Max Dragon Fruit 7-mg | 0.63 | 0.85 | 0.42 |
| Velo Max Wintergreen 7-mg | Velo Max Cinnamon 7-mg | 0.015 | 0.003 | 0.81 |
Summary of baseline-adjusted nicotine pharmacokinetic parameters_ Data are presented as mean (coefficient of variation) for Cmax and AUCnic 0–180, and median (minimum and maximum) for Tmax_
| Product | Nicotine per pouch (mg) | Cmax (ng/mL) | AUCnic 0–180 (ng × min/mL) | Tmax(min) |
|---|---|---|---|---|
| Velo Wintergreen | 4 | 11.224 (28.7%) | 1212.535 (27.4%) | 46.0 (30.00–73.00) |
| Velo Max Wintergreen | 7 | 16.807 (23.6%) | 1773.454 (25.1%) | 46.0 (30.00–90.00) |
| Velo Max Spearmint | 7 | 16.991 (27.9%) 1 | 1862.770 (25.2%) 1 | 46.0 (30.00–90.00) 1 |
| Velo Max Peppermint | 7 | 17.476 (32.5%) 1 | 1894.044 (30.6%) 1 | 46.0 (30.00–90.00) 1 |
| Velo Max Citrus Burst | 7 | 16.220 (33.3%) 1 | 1752.167 (31.2%) 1 | 46.0 (15.00–90.00) 1 |
| Velo Max Black Cherry | 7 | 17.322 (28.0%) 1 | 1872.012 (25.9%) 1 | 46.0 (30.00–90.00) 1 |
| Velo Max Coffee | 7 | 16.354 (28.9%) 1 | 1829.397 (23.7%) 1 | 46.0 (15.00–90.00) 1 |
| Velo Max Dragon Fruit | 7 | 16.648 (29.8%) 1 | 1775.659 (28.8%) 1 | 46.0 (30.00–90.00) 1 |
| Velo Max Cinnamon | 7 | 17.888 (26.2%) | 1965.491 (22.1%) | 46.0 (30.00–90.00) |
Summary of overall product-liking questionnaire scores_
| Product | Nicotine per pouch (mg) | Number of participants | Mean (SD) | Median | Min, max | Q1, Q3 |
|---|---|---|---|---|---|---|
| Velo Wintergreen | 4 | 41 | 5.8 (2.22) | 6 | 0, 10 | 4, 7 |
| Velo Max Wintergreen | 7 | 41 | 5.9 (2.25) | 6 | 1, 10 | 4, 8 |
| Velo Max Spearmint | 7 | 40 | 5.6 (2.30) | 6 | 0, 10 | 5, 7 |
| Velo Max Peppermint | 7 | 40 | 5.3 (2.13) | 6 | 0, 10 | 4, 7 |
| Velo Max Citrus Burst | 7 | 40 | 6.0 (2.52) | 6 | 0, 10 | 4, 8 |
| Velo Max Black Cherry | 7 | 40 | 5.1 (2.28) | 5 | 0, 10 | 4, 7 |
| Velo Max Coffee | 7 | 40 | 6.1 (2.88) | 6.5 | 0, 10 | 5, 8 |
| Velo Max Dragon Fruit | 7 | 40 | 6.1 (2.43) | 6 | 0, 10 | 5, 8 |
| Velo Max Cinnamon | 7 | 41 | 5.5 (2.67) | 6 | 0, 10 | 4, 7 |
Demographic data of study participants collected at screening_
| Variable | Number of participants | % | Mean (SD) |
|---|---|---|---|
| Age (years) | 42 | — | 40.4 – 11.38 |
| Sex | |||
| Male | 28 | 66.7 | — |
| Female | 14 | 33.3 | — |
| Weight (kg) | 42 | — | 81.17 – 17.02 |
| Height (cm) | 42 | — | 173.5 – 9.2 |
| BMI (kg/m2) | 42 | — | 26.8 – 4.45 |
| Race | |||
| White | 33 | 78.6 | — |
| Black / African American | 9 | 21.4 | — |
| Ethnicity | — | ||
| Hispanic or Latino | 6 | 14.3 | — |
| Not Hispanic or Latino | 36 | 85.7 | — |