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

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: 4 mg Nicotine Gum/; Drug: 2 mg Nicotine Gum; Drug: 6 mg Experimental nicotine gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01234792

NICTDP1070

2008-000596-15 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

NIC-6

Experimental group

Description:

6 mg Experimental nicotine gum

Treatment:

Drug: 6 mg Experimental nicotine gum

NIC-4

Active Comparator group

Description:

4 mg Nicotine Gum

Treatment:

Drug: 4 mg Nicotine Gum/

NIC-2

Active Comparator group

Description:

2 mg Nicotine Gum

Treatment:

Drug: 2 mg Nicotine Gum