Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Nicotine

• Registration Number: NCT01152723
• Lead Sponsor: McNeil AB

Brief Summary

Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.

Detailed Description

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 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. Treatment labels will be concealed from subjects and study personnel.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-05
• Study Completion: 2008-05
• 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: 28

Inclusion Criteria

• Healthy subjects, 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
UNG-GA	Nicotine	New NRT product
UNG-GB	Nicotine	New NRT product
Nicorette® Gum	Nicotine	Nicorette® Gum

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic measurements	Baseline and during 8 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
tmax	During 8 hours after start of product administration	The time of occurrence of Cmax following product administration
Lamda z	During 8 hours after start of product administration	The terminal nicotine elimination rate constant (λz)
Released amount of nicotine	After 30 minutes of chewing	The amount of nicotine released from gums during 30 minutes' chewing.

Trial Locations

Locations (1)

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