Overview

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McNeil AB
Treatments:
Nicotine
Criteria
Inclusion Criteria:

- Healthy smokers, smoking at least 15 cigarettes daily during at least one year
preceding inclusion and BMI between 17.5 and 30.0 kg/m2.

- 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 or donation or loss of blood within 3 months
preceding the first dose of study medication.