Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Johnson & Johnson Consumer and Personal Products Worldwide40 enrolled

Overview

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tobacco Dependence

Interventions

NicotineDRUG

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

Nicotine GumDRUG

Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.

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)

Clinical Trial Unit, Clinical Research and Trial Centre

Lund, Sweden

Outcomes

Primary Outcomes

Maximum Concentration

The maximum observed nicotine concentration in plasma (Cmax)

Time frame: Baseline to 10 hours post-dose

Area under the Curve

The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

Time frame: 10 hours post-dose

Secondary Outcomes

Time to Maximum Concentration

Time to Maximum Concentration (Tmax)

Time frame: 10 hours post-dose

Residual Nicotine

The amount of residual nicotine in the product after being chewed.

Time frame: 30 minutes

Dissolution Time

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

Time frame: 10 hours post-dose

Data from ClinicalTrials.gov

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