A Study to Investigate Nicotine Delivery in myblu C3-Design Liquidpods
Research type
Research Study
Full title
A Study to Investigate Nicotine Delivery From mybluTM C3-Design Liquidpods
IRAS ID
269451
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Nerudia Ltd
Duration of Study in the UK
0 years, 1 months, 19 days
Research summary
This study is an open-label, randomised pharmacokinetic study to examine the nicotine delivery and levels in the bloodstream of mybluTM C3-design liquidpods when compared to similar marketed e-liquid formulations using marketed mybluTM liquidpods and Vype iSwitch Maxx.
Cigarette smoking has been identified as a contributing factor to numerous illnesses including lung cancer, chronic obstructive lung disease and heart disease. The health risks associated with cigarette smoking are known to be due
to chemicals toxicants in cigarette smoke, which can lead to changes in the body, causing disease. Nicotine is primarily responsible for the addictive properties of cigarette smoking.
This study has been developed by the Sponsor in order to assist the development of an alternative approach to conventional cigarettes, by developing new products which may have the potential to reduce some of the risks of tobacco-related diseases namely “Next Generation Products” (NGP). These are nicotine-delivering devices such as electronic inhalable vapour products (e-cigarettes).The purpose of this study is to determine the levels of nicotine in the bloodstream when delivered from a newly designed mybluTM C3 liquidpods (of 3 different nicotine strengths) and compare this with the already marketed mybluTM liquidpods of comparative nicotine strengths and a marketed e-cigarette comparator device (Vype iSwitch Maxx).
This study will be conducted in 24 male and female subjects who are all daily e-cigarette users.
The study will consist of a screening visit, 7 treatment periods (of 1 day in duration, 12 hour washout between each period) and a follow up phone call.
REC name
Wales REC 2
REC reference
19/WA/0202
Date of REC Opinion
13 Aug 2019
REC opinion
Further Information Favourable Opinion