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

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers

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

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Oral Nicotine; Drug: NiQuitinTM Nicotine Lozenge; Drug: Nicorette® Nicotine Gum

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 222 20
    • Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nicotine 1; One oral administration of 1 mg nicotine	Drug: Oral Nicotine; A new l mg oral nicotine product; Other Names: Experimental nicotine 1 mg
Experimental: Oral Nicotine 2; Two oral administrations of 1 mg nicotine	Drug: Oral Nicotine; A new l mg oral nicotine product; Other Names: Experimental nicotine 1 mg
Experimental: Oral Nicotine 4; Four oral administrations of 1 mg nicotine	Drug: Oral Nicotine; A new l mg oral nicotine product; Other Names: Experimental nicotine 1 mg
Active Comparator: NiQuitinTM Nicotine Lozenge 4 mg; One 4 mg marketed nicotine lozenge	Drug: NiQuitinTM Nicotine Lozenge; A marketed 4 mg Nicotine lozenge; Other Names: NiQuitinTM lozenge
Active Comparator: Nicorette® Gum 4 mg; One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes	Drug: Nicorette® Nicotine Gum; A marketed 4 mg Nicotine Gum; Other Names: Nicorette® gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration	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)	During 12 hours after start of administration
Bioavailability	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).	12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Estimate): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Smoking Cessation; Nicotine pharmacokinetics
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICTDP1065/A6431116; 2008-006280-36 (EudraCT Number)