Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

McNeil AB76 enrolled

Overview

This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Tobacco Dependence

Interventions

NicotineDRUG

Single-dose of new NRT product

Nicotine GumDRUG

Single-dose of marketed nicotine gum

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

McNeil AB Clinical Pharmacology R&D

Lund, Sweden

Outcomes

Primary Outcomes

Pharmacokinetic measurements

Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax) * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) * the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

Time frame: Baseline and during 10 hours after product administration

Secondary Outcomes

tmax

The time of occurrence of Cmax following product administration

Time frame: Baseline and during 10 hours after product administration

Lamda z

The terminal nicotine elimination rate constant (λz)

Time frame: Baseline and during 10 hours after product administration

Released amount of nicotine

The amount of nicotine released from gums during 30 minutes' chewing.

Time frame: After 30 minutes of chewing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.