Pharmacokinetic Comparison Study of Two Nicotine Gum Products

• Research type

  Research Study

• Full title

  Comparative, Randomised, Single-Dose, 2-way Crossover Bioavailability Study of Fertin Pharma A/S and McNeil Consumer Healthcare GmbH (Nicorette® Freshmint) 4 mg Nicotine Mint Flavoured Chewing Gum in Healthy Adult Volunteers Under Fasting Conditions

• IRAS ID

  87568

• Sponsor organisation

  Fertin Pharma A/S

• Eudract number

  2011-004107-21

• Research summary

  The purpose of this study is to compare a new formulation of 4 mg nicotine gum a currently marketed one. The study will find out how much of and the rate at which nicotine gets into and is removed from the body from each of the two formulations.To investigate this, volunteers will chew a single dose of each of the two gum formulations in a random order on 2 separate occasions (i.e. 2 assessment periods) during the study and blood will be assessed and compared for nicotine levels for a period after. There will be an interval of at least 7 days between the two doses.Male and female volunteers who are smokers aged between 18-55 years will take part in this study at one centre in the UK.

• REC name

  HSC REC A

• REC reference

  11/NI/0126

• Date of REC Opinion

  1 Sep 2011

• REC opinion

  Favourable Opinion