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Clinical Trials/NCT01084603
NCT01084603CompletedNot Applicable

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers

McNeil AB1 site in 1 country45 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs

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

Experimental

One oral administration of 1 mg nicotine

Intervention: Oral Nicotine (Drug)

Oral Nicotine 2

Experimental

Two oral administrations of 1 mg nicotine

Intervention: Oral Nicotine (Drug)

Oral Nicotine 4

Experimental

Four oral administrations of 1 mg nicotine

Intervention: Oral Nicotine (Drug)

NiQuitinTM Nicotine Lozenge 4 mg

Active Comparator

One 4 mg marketed nicotine lozenge

Intervention: NiQuitinTM Nicotine Lozenge (Drug)

Nicorette® Gum 4 mg

Active Comparator

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)

Investigators

Sponsor
McNeil AB
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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