Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg - Full Text View

Purpose

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

Condition	Intervention
Tobacco Dependence	Drug: Nicotine Sublingual Tablet Mint (NSTM) Drug: Marketed Nicotine Tablet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg - A Study in Healthy Smokers

Resource links provided by NLM:

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: During 10 hours post-dose ] [ Designated as safety issue: No ]
Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)
Area Under the Curve (AUC)(0-t) [ Time Frame: During 10 hours post-dose ] [ Designated as safety issue: No ]
Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).
AUC(0-∞) [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).

Secondary Outcome Measures:

Product Dissolution Time [ Time Frame: During 10 hours post-dose ] [ Designated as safety issue: No ]
Product Dissolution Time is the time from administration until the investigational products were completely dissolved.

Enrollment:	40
Study Start Date:	September 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nicotine Sublingual Tablet Mint (NSTM)-2 Experimental 2 mg NSTM	Drug: Nicotine Sublingual Tablet Mint (NSTM) A single dose of an experimental NSTM, with a 36-hour washout between visits Other Name: Not marketed
Active Comparator: Microtab-2 2 mg Nicotine tablet	Drug: Marketed Nicotine Tablet A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits Other Name: Nicorette® Microtab
Experimental: NSTM-4 Experimental 4 mg Nicotine Sublingual Tablet Mint	Drug: Nicotine Sublingual Tablet Mint (NSTM) A single dose of an experimental NSTM, with a 36-hour washout between visits Other Name: Not marketed
Active Comparator: Microtab-4 2 x 2 mg Nicotine tablet	Drug: Marketed Nicotine Tablet A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits Other Name: Nicorette® Microtab

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238627

Locations

Sweden
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, SE-222 20

Sponsors and Collaborators

McNeil AB

Investigators

Study Director:

Elisabeth Kruse, PhD

McNeil AB

More Information

No publications provided

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:	NCT01238627 History of Changes
Other Study ID Numbers:	NICTDP1064-A6431115, 2007-002180-27
Study First Received:	November 9, 2010
Last Updated:	July 6, 2012
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Smoking Cessation
Nicotine pharmacokinetics

Additional relevant MeSH terms:

Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013