Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

McNeil AB88 enrolled

Overview

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tobacco Dependence

Interventions

NicotineDRUG

Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg

Nicorette® (Nicotine Gum)DRUG

Single-dose of marketed nicotine gum 2 mg or 4 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and 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)

Berzelius Clinical Research Center

Linköping, 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 (AUCinf)

Time frame: Baseline and during 10 hours after product administration

Secondary Outcomes

Tmax

The time of occurrence of Cmax (tmax) following product administration

Time frame: during 10 hours after start of product administration

λz

The terminal nicotine elimination rate constant (λz)

Time frame: during 10 hours after start of product administration

Residual Nicotine

The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.

Time frame: After 30 minutes of chewing

Dissolution Time

Actual time required for oral dissolution of new NRT products following product administration

Time frame: From product administration until completely dissolved

Data from ClinicalTrials.gov

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