Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Nicorette® (Nicotine Gum); Drug: Nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113424

2008-003358-14 (EudraCT Number)

NICTDP1071

Details and patient eligibility

About

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Full description

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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: 88 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

NRT-2

Experimental group

Description:

2 mg single-dose of a new NRT product

Treatment:

Drug: Nicotine

GUM-2

Active Comparator group

Description:

2 mg single-dose of a marketed nicotine gum

Treatment:

Drug: Nicorette® (Nicotine Gum)

NRT-4

Experimental group

Description:

4 mg single-dose of a new NRT product

Treatment:

Drug: Nicotine

GUM-4

Active Comparator group

Description:

4 mg single-dose of marketed nicotine gum

Treatment:

Drug: Nicorette® (Nicotine Gum)