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

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Nicotine Lozenge; Drug: Nicotine gum; Drug: Oral Nicotine

• Registration Number: NCT01084707
• Lead Sponsor: McNeil AB

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Results First Submitted: 2010-04-16
• Results First Submitted QC: 2010-10-01
• Results First Posted: 2010-10-19
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NiQuitin™ Lozenge 4 mg	Nicotine Lozenge	1 NiQuitin™ lozenge, administered by study personnel once every hour
Nicorette® Gum 4 mg	Nicotine gum	1 piece Nicorette® gum, chewed for 30 minutes once every hour
Oral Nicotine 24-SA	Oral Nicotine	2 Self-administrations of Experimental Nicotine once every hour
Oral Nicotine 24	Oral Nicotine	2 administrations of Experimental Nicotine by study personnel once every hour
Oral Nicotine 48	Oral Nicotine	2 administrations of Experimental Nicotine by study personnel once every 30 minutes

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration	During the last dosing interval (hour 11-12 post-dose)	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)
Average Concentration	During the last dosing interval (hour 11-12 post-dose)	Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Pharmacology; 🇸🇪 Lund, Sweden