drugset / Trial / NCT01478230

An Exploratory Study Comparing Two Nicotine Inhalers

NCT01478230

Phase 0 Completed 36 enrolled McNeil AB
RandomizedCrossoverOpen-label

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.

Timeline

Start
2011-11
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicotine Unknown 5 mg Other
Comparator Nicotine Unknown 10 mg Other

Indications