Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Oral Nicotine; Drug: Nicotine Lozenge; Drug: Nicotine gum

Detailed Description

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 222 20
    • Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy smokers, smoking at least 20 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.
• Prior regular use of nicotine mouth spray

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nicotine 24-SA; 2 Self-administrations of Experimental Nicotine once every hour	Drug: Oral Nicotine; Oral Nicotine either self-administered or provided by study personnel within 12 hours; Other Names: generic Nicotine
Experimental: Oral Nicotine 24; 2 administrations of Experimental Nicotine by study personnel once every hour	Drug: Oral Nicotine; Oral Nicotine either self-administered or provided by study personnel within 12 hours; Other Names: generic Nicotine
Experimental: Oral Nicotine 48; 2 administrations of Experimental Nicotine by study personnel once every 30 minutes	Drug: Oral Nicotine; Oral Nicotine either self-administered or provided by study personnel within 12 hours; Other Names: generic Nicotine
Active Comparator: NiQuitin™ Lozenge 4 mg; 1 NiQuitin™ lozenge, administered by study personnel once every hour	Drug: Nicotine Lozenge; Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours; Other Names: NiQuitin™
Active Comparator: Nicorette® Gum 4 mg; 1 piece Nicorette® gum, chewed for 30 minutes once every hour	Drug: Nicotine gum; Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours; Other Names: Nicorette®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration	Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)	During the last dosing interval (hour 11-12 post-dose)
Average Concentration	Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)	During the last dosing interval (hour 11-12 post-dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During the last dosing interval (hour 11-12 post-dose)
Minimum Plasma Concentration	The minimum nicotine plasma concentration during the last dosing interval (Cmin)	During the last dosing interval (hour 11-12 post-dose)
Peak-Trough Fluctuation	Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)	During the last dosing interval (hour 11-12 post-dose)
Nicotine Plasma Concentration	The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment	One hour after start of treatment

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Estimate): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Smoking Cessation, Nicotine pharmacokinetics
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICTDP1066-A6431117; 2008-006279-65 (EudraCT Number)