A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients

Summary

This study will compare nicotine delivery and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union.

Conditions

• Healthy Volunteers
• Smoking

Interventions

OTHER

Reference cigarette

The reference product is based on a commercially-available king-size cigarette design (length 83 mm, circumference 24.6 mm) with a single segment cellulose acetate filter and tobacco blend recipe without ingredients.

OTHER

Cigarette with carob bean extract

Based on reference cigarette with added ingredient

OTHER

Cigarette with cocoa powder

Based on reference cigarette with added ingredient

OTHER

Cigarette with fenugreek extract

Based on reference cigarette with added ingredient

OTHER

Cigarette with fig juice

Based on reference cigarette with added ingredient

OTHER

Cigarette with glycerol

Based on reference cigarette with added ingredient

OTHER

Cigarette with guaiacol

Based on reference cigarette with added ingredient

OTHER

Cigarette with liquorice extract powder

Based on reference cigarette with added ingredient

OTHER

Cigarette plus I-menthol

Based on reference cigarette with added ingredient

OTHER

Cigarette with propylene glycol

Based on reference cigarette with added ingredient

OTHER

Cigarette with sorbitol

Based on reference cigarette with added ingredient

OTHER

Cigarette with multiple ingredients

Based on reference cigarette plus propylene glycol, glycerol, liquorice extract powder, cocoa powder, carob bean extract, fig juice concentrate, maltol, guaiacol, geraniol, fenugreek extract.

Sponsors & Collaborators

• Philip Morris Products S.A.

  collaborator INDUSTRY

• Imperial Brands PLC

  collaborator INDUSTRY

• Japan Tobacco Inc.

  collaborator INDUSTRY

• Korea Ginseng Corporation

  collaborator INDUSTRY

• British American Tobacco (Investments) Limited

  lead INDUSTRY

Principal Investigators

• Johnston Stewart, MB · Celerion GB Ltd

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-12

Primary Completion

2017-12-08

Completion

2017-12-08

Countries

• United Kingdom

Study Locations