Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

• 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 months preceding the first dose of study medication.