Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study DOI Creative Commons
Milly N. Kanobe, Patrudu Makena, Kristen Prevette

и другие.

European Journal of Drug Metabolism and Pharmacokinetics, Год журнала: 2024, Номер 49(6), С. 733 - 750

Опубликована: Окт. 25, 2024

Heated tobacco products (HTPs) are a class of non-combustible, inhaled with the potential to reduce harm associated cigarette smoking due reduced smoke toxicant exposure. Subjective and nicotine pharmacokinetics measures taken over course product use provide framework for abuse liability (AL) assessment as well information on adoption new product, which important aspects premarket authorization by US Food Drug Administration. This study aimed assess AL glo HTPs, operated in either Standard or Boost Modes, compared high- low-AL comparators (subjects' usual brand cigarettes gum, respectively). Nicotine uptake pharmacodynamics (including subjective physiological measures) were assessed clinical 75 healthy adult non-menthol menthol smokers using an open-label, randomized crossover design. Comparisons made between HTPs (Standard Modes) each (UB) gum evaluate exposure effects measures. uptake, reflected area under curve (AUC) at 15 240 min after (AUC0-15 AUC0-240, respectively) maximum concentration (Cmax) significantly lower all UB cigarettes, regardless device mode. AUC0-15 values ranged from 41.26 75.71 ng × min/mL, versus 158.04 165.53 min/mL cigarettes. Similarly, AUC0-240 379 596 1123.73 1283.37 The Cmax 5.46 9.00 ng/mL, whereas had 16.29 16.76 ng/mL. time reach (Tmax) was shorter (4–5 min) (6–7 min), except one variant HTP Mode. exhibited slower absorption profile, Tmax 45 4.60 6.18 5.22 647.80 687.68 groups, respectively. indicated that rated than terms liking, urge reduction, effects, intent again, but comparable gum. demonstrated combustible while delivering sufficient support among current smokers. positions tool offering less harmful alternative traditional Clinical trial ID NCT05114863.

Язык: Английский

Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study DOI Creative Commons
Milly N. Kanobe, Patrudu Makena, Kristen Prevette

и другие.

European Journal of Drug Metabolism and Pharmacokinetics, Год журнала: 2024, Номер 49(6), С. 733 - 750

Опубликована: Окт. 25, 2024

Heated tobacco products (HTPs) are a class of non-combustible, inhaled with the potential to reduce harm associated cigarette smoking due reduced smoke toxicant exposure. Subjective and nicotine pharmacokinetics measures taken over course product use provide framework for abuse liability (AL) assessment as well information on adoption new product, which important aspects premarket authorization by US Food Drug Administration. This study aimed assess AL glo HTPs, operated in either Standard or Boost Modes, compared high- low-AL comparators (subjects' usual brand cigarettes gum, respectively). Nicotine uptake pharmacodynamics (including subjective physiological measures) were assessed clinical 75 healthy adult non-menthol menthol smokers using an open-label, randomized crossover design. Comparisons made between HTPs (Standard Modes) each (UB) gum evaluate exposure effects measures. uptake, reflected area under curve (AUC) at 15 240 min after (AUC0-15 AUC0-240, respectively) maximum concentration (Cmax) significantly lower all UB cigarettes, regardless device mode. AUC0-15 values ranged from 41.26 75.71 ng × min/mL, versus 158.04 165.53 min/mL cigarettes. Similarly, AUC0-240 379 596 1123.73 1283.37 The Cmax 5.46 9.00 ng/mL, whereas had 16.29 16.76 ng/mL. time reach (Tmax) was shorter (4–5 min) (6–7 min), except one variant HTP Mode. exhibited slower absorption profile, Tmax 45 4.60 6.18 5.22 647.80 687.68 groups, respectively. indicated that rated than terms liking, urge reduction, effects, intent again, but comparable gum. demonstrated combustible while delivering sufficient support among current smokers. positions tool offering less harmful alternative traditional Clinical trial ID NCT05114863.

Язык: Английский

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