Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Nicotine Medicated Gum; Drug: 4 mg Nicotine Gum; Drug: 2 mg Nicotine Gum; Drug: 4 mg Nicotine Lozenge

Detailed Description

Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-222 20
    • McNeil AB Clinical Pharmacology R&D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms.
• 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 month preceding the first dose of study medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nicotine Gum 6; 6 mg Nicotine medicated gum	Drug: Nicotine Medicated Gum; Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes; Other Names: Not marketed
Active Comparator: Nicotine Gum 4; 4 mg Nicotine Gum	Drug: 4 mg Nicotine Gum; Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes; Other Names: Nicorette® Freshfruit gum
Active Comparator: Nicotine Gum 2; 2 mg Nicotine Gum	Drug: 2 mg Nicotine Gum; Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes; Other Names: Nicorette® Freshfruit gum
Active Comparator: Nicotine Lozenge; 4 mg Nicotine Lozenge	Drug: 4 mg Nicotine Lozenge; Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved; Other Names: NiQuitin™ Mint lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)	12 hours post-dose
Area Under the Curve (AUC)(0-t)	AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).	12 hours post-dose
AUC (0-∞)	AUC (0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.	12 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(10 min)	AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes	10 minutes post-dose

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 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: NICTDP1080; 2010-021087-15 (EudraCT Number)