An Exploratory Study Comparing Two Nicotine Inhalers
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Subjects will be screened within 28 days before the first study treatment to confirm that
they meet the requirements to participate in the trial. They will return to the site for two
treatment visits, at least 12 hours each, and at least one day in between visits. At each
visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11
hours. The investigator (or an appropriate delegate at the investigator site) will obtain
informed consent from each subject. Blood samples will be drawn on a special schedule. The
total predicted amount of blood sampled from each subject is 174 mL over the whole study.
Subjects will be required to follow specific smoking and dietary restrictions and rate their
urges to smoke, general liking of the product, and how easy the product is to use.