Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

McNeil AB24 enrolled

Overview

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Tobacco Dependence

Interventions

6 mg Experimental nicotine gumDRUG

A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits

4 mg Nicotine Gum/DRUG

A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits

2 mg Nicotine GumDRUG

A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg. * 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

Maximum Observed Plasma Concentration (Cmax)

Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

Time frame: During 8 hours post-dose

Area Under the Curve (AUC)(0-t)

AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).

Time frame: During 8 hours post-dose

AUC(0-∞)

AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Time frame: 8 hours post-dose

Data from ClinicalTrials.gov

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