Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Nicotine; Drug: Nicotine Gum

• Registration Number: NCT01152749
• Lead Sponsor: McNeil AB

Brief Summary

This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Detailed Description

The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

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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
UNG-GC-4	Nicotine	4 mg experimental NRT product
Nicorette® Gum-2	Nicotine Gum	2 mg Nicorette® Gum
UNG-GC-2	Nicotine	2 mg experimental NRT product
Nicorette® Gum-4	Nicotine Gum	4 mg Nicorette® Gum

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 (AUC∞)

Secondary Outcome Measures

Name	Time	Method
Released amount of nicotine	After 30 minutes of chewing	The amount of nicotine released from gums during 30 minutes' chewing.
Lamda z	Baseline and during 10 hours after product administration	The terminal nicotine elimination rate constant (λz)
tmax	Baseline and during 10 hours after product administration	The time of occurrence of Cmax following product administration

Trial Locations

Locations (1)

McNeil AB Clinical Pharmacology R&D; 🇸🇪 Lund, Sweden