Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

McNeil AB104 enrolled

Overview

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Tobacco Dependence

Interventions

Experimental Nicotine Replacement Therapy (NRT) 2 mgDRUG

2 mg Single-dose of new NRT product (NSL2L)

Experimental Nicotine Replacement Therapy (NRT)DRUG

4 mg Single-dose of new NRT product

Marketed Nicotine LozengeDRUG

2 mg Single-dose of marketed lozenge

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (2)

Lund University Hospital Clinical Trial Unit

Lund, Sweden

McNeil AB Clinical Pharmacology R&D

Lund, Sweden

Outcomes

Primary Outcomes

Maximum Plasma Concentration

The maximum observed nicotine concentration in plasma (Cmax)

Time frame: during 12 hours after product administration

Area under the Curve

The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

Time frame: after 12 hours

Secondary Outcomes

Time of Maximum Concentration

The time of occurrence of maximum concentration (Tmax)

Time frame: during 12 hours after start of product administration

Terminal Elimination Rate Constant

The terminal nicotine elimination rate constant (λz)

Time frame: during 12 hours after start of product administration

Oral Dissolution Time

Actual time required for oral dissolution

Time frame: from administration until completely dissolved

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.