N/A N=40 Randomized Treatment

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

Tobacco Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01084707 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2010

Primary outcome: Primary: Maximum Plasma Concentration — 15.43; 16.49; 30.07; 27.07 (ng/ml)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Oral Nicotine (Drug); Nicotine Lozenge (Drug); Nicotine gum (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: McNeil AB
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration	15.43; 16.49; 30.07; 27.07; 25.96	—
PRIMARY Average Concentration	13.33; 14.04; 27.50; 23.70; 22.15	—
SECONDARY Time of Maximum Concentration	15.0; 10.0; 10.0; 25.0; 30.0	—
SECONDARY Minimum Plasma Concentration	11.54; 11.67; 25.32; 22.14; 19.00	—
SECONDARY Peak-Trough Fluctuation	35.6; 38.4; 21.7; 29.1; 36.3	—
SECONDARY Nicotine Plasma Concentration	4.49; 4.76	—

Summary

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

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01084707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.