Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McNeil AB
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration
Study Overview
Brief Summary
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
Detailed 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy smokers, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m
- •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 months preceding the first dose of study medication.
Arms & Interventions
Oral Nicotine 1
One oral administration of 1 mg nicotine
Intervention: Oral Nicotine (Drug)
Oral Nicotine 2
Two oral administrations of 1 mg nicotine
Intervention: Oral Nicotine (Drug)
Oral Nicotine 4
Four oral administrations of 1 mg nicotine
Intervention: Oral Nicotine (Drug)
NiQuitinTM Nicotine Lozenge 4 mg
One 4 mg marketed nicotine lozenge
Intervention: NiQuitinTM Nicotine Lozenge (Drug)
Nicorette® Gum 4 mg
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
Intervention: Nicorette® Nicotine Gum (Drug)
Outcomes
Primary Outcomes
Maximum Plasma Concentration
Time Frame: During 12 hours after start of administration
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Bioavailability
Time Frame: 12 hours
A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\*nanograms/milliliter (h\*ng/ml).
Secondary Outcomes
- Nicotine Plasma Concentration(During 10 minutes after start of administration)
- Time of Maximum Concentration(During 12 hours after start of administration)
- Terminal Elimination Rate Constant(During 12 hours after start of administration)
- Released Nicotine(After 30 minutes' chewing)