Overview

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McNeil AB
Treatments:
Nicotine
Criteria
Inclusion Criteria:

- Healthy subjects, smoking more than 20 cigarettes daily during at least one year
preceding inclusion.

- Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least
55.0 kg.

- Female participants of child-bearing potential are required to use a medically
acceptable means of birth control.

- A personally signed and dated informed consent document, indicating that the subject
has been informed of all pertinent aspects of the study.

Exclusion Criteria:

- Pregnancy, lactation or intended pregnancy.

- Treatment with an investigational product within one month preceding the first dose of
study medication.