Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Nicotine; Drug: Nicorette® (Nicotine Gum)

• Registration Number: NCT01113424
• Lead Sponsor: McNeil AB

Brief Summary

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Detailed Description

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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: 2008-09
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NRT-2	Nicotine	2 mg single-dose of a new NRT product
GUM-4	Nicorette® (Nicotine Gum)	4 mg single-dose of marketed nicotine gum
GUM-2	Nicorette® (Nicotine Gum)	2 mg single-dose of a marketed nicotine gum
NRT-4	Nicotine	4 mg single-dose of a new NRT product

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic measurements	Baseline and during 10 hours after product administration	Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax); * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt); * the area under the plasma concentration-vs.-time curve until infinity (AUCinf)

Secondary Outcome Measures

Name	Time	Method
Dissolution Time	From product administration until completely dissolved	Actual time required for oral dissolution of new NRT products following product administration
λz	during 10 hours after start of product administration	The terminal nicotine elimination rate constant (λz)
Tmax	during 10 hours after start of product administration	The time of occurrence of Cmax (tmax) following product administration
Residual Nicotine	After 30 minutes of chewing	The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.

Trial Locations

Locations (1)

Berzelius Clinical Research Center; 🇸🇪 Linköping, Sweden