Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil AB
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.

• BMI between 17.5 and 30.0 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.

• Willing and able to comply with all scheduled visits and study procedures

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.

• Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.