Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - Full Text View

Purpose

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

Condition	Intervention
Tobacco Dependence	Drug: Nicotine Drug: Nicotine Gum

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers

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 Concentration [ Time Frame: Baseline to 10 hours post-dose ] [ Designated as safety issue: No ]
The maximum observed nicotine concentration in plasma (Cmax)
Area under the Curve [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

Secondary Outcome Measures:

Time to Maximum Concentration [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
Time to Maximum Concentration (Tmax)
Residual Nicotine [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
The amount of residual nicotine in the product after being chewed.
Dissolution Time [ Time Frame: 10 hours post-dose ] [ Designated as safety issue: No ]
Actual time required for oral dissolution of new NRT products following product administration

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

Arms	Assigned Interventions
Experimental: A1 Short, no buffer Nicotine / not yet marketed	Drug: Nicotine Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day Other Name: Not yet marketed
Experimental: A2 Short, low buffer Nicotine / not yet marketed	Drug: Nicotine Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day Other Name: Not yet marketed
Experimental: A3 Short, high buffer Nicotine / not yet marketed	Drug: Nicotine Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day Other Name: Not yet marketed
Experimental: B1 Long, no buffer Nicotine / not yet marketed	Drug: Nicotine Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day Other Name: Not yet marketed
Experimental: B2 Long, low buffer Nicotine / not yet marketed	Drug: Nicotine Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day Other Name: Not yet marketed
Experimental: B3 Long, high buffer Nicotine / not yet marketed	Drug: Nicotine Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day Other Name: Not yet marketed
Active Comparator: R = Nicotine Gum Nicorette® Gum	Drug: Nicotine Gum Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes. Other Name: Nicorette®

Detailed Description:

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

Eligibility

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

Criteria

Inclusion Criteria:

Healthy smokers, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228617

Locations

Sweden
Clinical Trial Unit, Clinical Research and Trial Centre
Lund, Sweden, SE-221 85

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

Study Director:

Elisabeth Kruse, PhD

McNeil AB

More Information

No publications provided

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT01228617 History of Changes
Other Study ID Numbers:	A6431114-NICTDP1063
Study First Received:	October 25, 2010
Last Updated:	October 4, 2011
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 21, 2013