Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Nicotine Gum; Drug: Nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152749

NICTDP1075

2009-010633-44 (EudraCT Number)

Details and patient eligibility

About

This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Full description

The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

Enrollment: 76 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (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: Quadruple Blind

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76 participants in 4 patient groups

UNG-GC-2

Experimental group

Description:

2 mg experimental NRT product

Treatment:

Drug: Nicotine

UNG-GC-4

Experimental group

Description:

4 mg experimental NRT product

Treatment:

Drug: Nicotine

Nicorette® Gum-2

Active Comparator group

Description:

2 mg Nicorette® Gum

Treatment:

Drug: Nicotine Gum

Nicorette® Gum-4

Active Comparator group

Description:

4 mg Nicorette® Gum

Treatment:

Drug: Nicotine Gum