Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: 4 mg Nicotine Lozenge; Drug: Nicotine Medicated Gum; Drug: 4 mg Nicotine Gum; Drug: 2 mg Nicotine Gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01234896

NICTDP1080

2010-021087-15 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 4 patient groups

Nicotine Gum 6

Experimental group

Description:

6 mg Nicotine medicated gum

Treatment:

Drug: Nicotine Medicated Gum

Nicotine Gum 4

Active Comparator group

Description:

4 mg Nicotine Gum

Treatment:

Drug: 4 mg Nicotine Gum

Nicotine Gum 2

Active Comparator group

Description:

2 mg Nicotine Gum

Treatment:

Drug: 2 mg Nicotine Gum

Nicotine Lozenge

Active Comparator group

Description:

4 mg Nicotine Lozenge

Treatment:

Drug: 4 mg Nicotine Lozenge