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

NCT ID: NCT01238627

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Tobacco Dependence

Keywords

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Smoking Cessation Nicotine pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nicotine Sublingual Tablet Mint (NSTM)-2

Experimental 2 mg NSTM

Group Type EXPERIMENTAL

Nicotine Sublingual Tablet Mint (NSTM)

Intervention Type DRUG

A single dose of an experimental NSTM, with a 36-hour washout between visits

Microtab-2

2 mg Nicotine tablet

Group Type ACTIVE_COMPARATOR

Marketed Nicotine Tablet

Intervention Type DRUG

A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits

NSTM-4

Experimental 4 mg Nicotine Sublingual Tablet Mint

Group Type EXPERIMENTAL

Nicotine Sublingual Tablet Mint (NSTM)

Intervention Type DRUG

A single dose of an experimental NSTM, with a 36-hour washout between visits

Microtab-4

2 x 2 mg Nicotine tablet

Group Type ACTIVE_COMPARATOR

Marketed Nicotine Tablet

Intervention Type DRUG

A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits

Interventions

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Nicotine Sublingual Tablet Mint (NSTM)

A single dose of an experimental NSTM, with a 36-hour washout between visits

Intervention Type DRUG

Marketed Nicotine Tablet

A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits

Intervention Type DRUG

Other Intervention Names

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Not marketed Nicorette® Microtab

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

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McNeil AB Clinical Pharmacology R&D

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2007-002180-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1064-A6431115

Identifier Type: -

Identifier Source: org_study_id