Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

McNeil AB44 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Tobacco Dependence

Interventions

Nicotine Medicated GumDRUG

Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes

4 mg Nicotine GumDRUG

Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes

2 mg Nicotine GumDRUG

Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

McNeil AB Clinical Pharmacology R&D

Lund, Sweden

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

Time frame: 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).

Time frame: 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.

Time frame: 12 hours post-dose

Secondary Outcomes

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

Time frame: 10 minutes post-dose

Data from ClinicalTrials.gov

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