Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Nicotine Lozenge; Drug: Oral Nicotine; Drug: Nicotine gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084707

NICTDP1066-A6431117

2008-006279-65 (EudraCT Number)

Details and patient eligibility

About

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

Full 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 steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy smokers, smoking at least 20 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 month preceding the first dose of study medication.
• Prior regular use of nicotine mouth spray

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 5 patient groups

Oral Nicotine 24-SA

Experimental group

Description:

2 Self-administrations of Experimental Nicotine once every hour

Treatment:

Drug: Oral Nicotine

Oral Nicotine 24

Experimental group

Description:

2 administrations of Experimental Nicotine by study personnel once every hour

Treatment:

Drug: Oral Nicotine

Oral Nicotine 48

Experimental group

Description:

2 administrations of Experimental Nicotine by study personnel once every 30 minutes

Treatment:

Drug: Oral Nicotine

NiQuitin™ Lozenge 4 mg

Active Comparator group

Description:

1 NiQuitin™ lozenge, administered by study personnel once every hour

Treatment:

Drug: Nicotine Lozenge

Nicorette® Gum 4 mg

Active Comparator group

Description:

1 piece Nicorette® gum, chewed for 30 minutes once every hour

Treatment:

Drug: Nicotine gum