Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
brief summary
This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over).
detailed description
Study Title:
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Who carried out the research? This research was sponsored and funded by Philip Morris Products S.A.
What public involvement there was in the study? The study recruited 31 healthy adults who were currently smoking.
Where and when the study took place The study was conducted at a clinical trial facility managed by a contract research organization in Belfast, Northern Ireland, from March 15th to August 18th 2022.
Why was the research needed? The research was needed to understand the pharmacokinetic profiles of four variants of a nicotine pouch.
What were the main questions studied? The study measured the nicotine absorption of the four variants of nicotine pouch (NP-1; NP-2; NP-3; NP-4) together with two nicotine pouches marketed by other companies (Zyn-NP and Velo-NP). Participants were also asked to evaluate their experience of using the nicotine pouches.
Who participated in the study? The study recruited 31 healthy, male or female, adults aged between 21 and 65 years who were currently smoking. The subjects did not plan to quit using tobacco and/or nicotine products within the next 3 months and had smoked continuously for at least the last 3 years prior to joining the study..
Each subject was given full and adequate oral and written information about the nature, purpose, possible risks and benefits of the study. Once each subject had received all the necessary information, and if he/she agreed to participate, this was documented in an Informed Consent Form with the date, time and signature of both the subject and the Investigator.
Subjects were informed that they were free to withdraw from the study at any time.
What treatments or interventions did the participants take/receive? The participants were requested to use a tobacco-free nicotine pouch for a period of 30 minutes. Blood samples were taken before, during, and after the product use period.
Participants were also asked to evaluate their experience of using the nicotine pouches, using the Product Evaluation Scale (PES).
official title
A Single-center, Randomized, Controlled, Open-label Study to Investigate the Nicotine Pharmacokinetic Profiles and Subjective Effects of Four Variants of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers