Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Drug: Oral Nicotine; Drug: NiQuitinTM Nicotine Lozenge; Drug: Nicorette® Nicotine Gum

• Registration Number: NCT01084603
• Lead Sponsor: McNeil AB

Brief Summary

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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: 2009-03
• Primary Completion: 2009-05
• Study Completion: 2009-06
• 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: 2010-06-10
• Results First Posted: 2010-07-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Healthy smokers, smoking at least 15 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 months preceding the first dose of study medication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral Nicotine 2	Oral Nicotine	Two oral administrations of 1 mg nicotine
Oral Nicotine 4	Oral Nicotine	Four oral administrations of 1 mg nicotine
NiQuitinTM Nicotine Lozenge 4 mg	NiQuitinTM Nicotine Lozenge	One 4 mg marketed nicotine lozenge
Oral Nicotine 1	Oral Nicotine	One oral administration of 1 mg nicotine
Nicorette® Gum 4 mg	Nicorette® Nicotine Gum	One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration	During 12 hours after start of administration	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)
Bioavailability	12 hours	A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\*nanograms/milliliter (h\*ng/ml).

Secondary Outcome Measures

Name	Time	Method
Nicotine Plasma Concentration	During 10 minutes after start of administration	Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
Time of Maximum Concentration	During 12 hours after start of administration	The time at which maximum concentration is reached (Tmax)
Terminal Elimination Rate Constant	During 12 hours after start of administration	The terminal nicotine elimination rate constant (Lamda z)
Released Nicotine	After 30 minutes' chewing	The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing

Trial Locations

Locations (1)

Clinical Pharmacology; 🇸🇪 Lund, Sweden