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

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Oral Nicotine; Drug: NiQuitinTM Nicotine Lozenge; Drug: Nicorette® Nicotine Gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084603

NICTDP1065/A6431116

2008-006280-36 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 5 patient groups

Oral Nicotine 1

Experimental group

Description:

One oral administration of 1 mg nicotine

Treatment:

Drug: Oral Nicotine

Oral Nicotine 2

Experimental group

Description:

Two oral administrations of 1 mg nicotine

Treatment:

Drug: Oral Nicotine

Oral Nicotine 4

Experimental group

Description:

Four oral administrations of 1 mg nicotine

Treatment:

Drug: Oral Nicotine

NiQuitinTM Nicotine Lozenge 4 mg

Active Comparator group

Description:

One 4 mg marketed nicotine lozenge

Treatment:

Drug: NiQuitinTM Nicotine Lozenge

Nicorette® Gum 4 mg

Active Comparator group

Description:

One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes

Treatment:

Drug: Nicorette® Nicotine Gum