Overview

Bioequivalence Between an Oral Nicotine Replacement Product and NicoretteĀ® Gum

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
This study examines the bioequivalence between an oral nicotine replacement product and NicoretteĀ® gum.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McNeil AB
Treatments:
Nicotine
Criteria
Inclusion Criteria:

- Healthy subjects, smoking at least 10 cigarettes daily during at least one year
preceding inclusion and body mass index (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 month
preceding the first dose of study medication.