Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

McNeil AB45 enrolled

Overview

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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

Oral NicotineDRUG

A new l mg oral nicotine product

NiQuitinTM Nicotine LozengeDRUG

A marketed 4 mg Nicotine lozenge

Nicorette® Nicotine GumDRUG

A marketed 4 mg Nicotine Gum

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy smokers, smoking at least 15 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 months preceding the first dose of study medication.

Locations (1)

Clinical Pharmacology

Lund, Sweden

Outcomes

Primary Outcomes

Maximum Plasma Concentration

Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

Time frame: During 12 hours after start of administration

Bioavailability

A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\*nanograms/milliliter (h\*ng/ml).

Time frame: 12 hours

Secondary Outcomes

Nicotine Plasma Concentration

Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)

Time frame: During 10 minutes after start of administration

Time of Maximum Concentration

The time at which maximum concentration is reached (Tmax)

Time frame: During 12 hours after start of administration

Terminal Elimination Rate Constant

The terminal nicotine elimination rate constant (Lamda z)

Time frame: During 12 hours after start of administration

Released Nicotine

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

Time frame: After 30 minutes' chewing

Data from ClinicalTrials.gov

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