Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Nicotine Sublingual Tablet Mint (NSTM); Drug: Marketed Nicotine Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238627

2007-002180-27 (EudraCT Number)

NICTDP1064-A6431115

Details and patient eligibility

About

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

Full description

The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.

Enrollment: 40 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 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 months preceding the first dose of study medication.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Nicotine Sublingual Tablet Mint (NSTM)-2

Experimental group

Description:

Experimental 2 mg NSTM

Treatment:

Drug: Nicotine Sublingual Tablet Mint (NSTM)

Microtab-2

Active Comparator group

Description:

2 mg Nicotine tablet

Treatment:

Drug: Marketed Nicotine Tablet

NSTM-4

Experimental group

Description:

Experimental 4 mg Nicotine Sublingual Tablet Mint

Treatment:

Drug: Nicotine Sublingual Tablet Mint (NSTM)

Microtab-4

Active Comparator group

Description:

2 x 2 mg Nicotine tablet

Treatment:

Drug: Marketed Nicotine Tablet