Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

McNeil-PPC

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg; Drug: Marketed Nicotine Lozenge; Drug: Experimental Nicotine Replacement Therapy (NRT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227720

NICTDP1076

Details and patient eligibility

About

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Full description

This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Enrollment: 104 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy subjects, smoking at least 10 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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104 participants in 6 patient groups

A NSL2L

Experimental group

Description:

Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg

Treatment:

Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg

B Lozenge

Active Comparator group

Description:

Marketed Nicotine Lozenge 2 mg

Treatment:

Drug: Marketed Nicotine Lozenge

Drug: Marketed Nicotine Lozenge

C NSL4M

Experimental group

Description:

Experimental NRT (M) 4 mg

Treatment:

Drug: Experimental Nicotine Replacement Therapy (NRT)

D Lozenge

Active Comparator group

Description:

Marketed Nicotine Lozenge 4 mg

Treatment:

Drug: Marketed Nicotine Lozenge

Drug: Marketed Nicotine Lozenge

E NSL4L

Experimental group

Description:

Experimental NRT (L) 4 mg

Treatment:

Drug: Experimental Nicotine Replacement Therapy (NRT)

F NSL4H

Experimental group

Description:

Experimental NRT (H) 4 mg

Treatment:

Drug: Experimental Nicotine Replacement Therapy (NRT)