Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• BMI within the range of 19 to 30 kilograms/meters^2

• Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

• Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids

• Treatment with known hepatic enzyme altering agents