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

NCT01084707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-07-13

Study results available
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Summary

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

Conditions

  • Tobacco Dependence

Interventions

DRUG

Oral Nicotine

Oral Nicotine either self-administered or provided by study personnel within 12 hours

DRUG

Nicotine Lozenge

Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours

DRUG

Nicotine gum

Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084707 on ClinicalTrials.gov