Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Code STE; Drug: Code STD; Drug: Nicorette Microtab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238640

2008-002788-15 (EudraCT Number)

NICTDP1072

Details and patient eligibility

About

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Full description

The trial has a single-dose, randomized, crossover design and includes 84 subjects. 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. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Enrollment: 84 patients

Sex: All

Ages: 18 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 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: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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84 participants in 3 patient groups

Code STD

Experimental group

Description:

An experimental 2 mg nicotine product coded "STD"

Treatment:

Drug: Code STD

Code STE

Experimental group

Description:

An experimental 2 mg nicotine product coded "STE"

Treatment:

Drug: Code STE

Nicorette Microtab

Active Comparator group

Description:

A comparative 2 mg marketed nicotine product called Nicorette Microtab

Treatment:

Drug: Nicorette Microtab