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Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers

NCT02906995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-12-04

No results posted yet for this study

Summary

The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.

Conditions

  • Tobacco Use Disorder
  • Cigarette Smoking

Interventions

DRUG

Sublingual tablet 4 mg versus Nicorette Lozenge 4mg

* One dose of study drug (sublingual tablet or Nicorette Lozenge) will be administered to each subject in the morning on Day 1. * The second administration of drug will occur at least 48 hours after the initial administration. Subjects will receive the other dosage form and be instructed according to whether they are receiving the sublingual tablet or the lozenge.

Sponsors & Collaborators

  • Rose Research Center, LLC

    collaborator INDUSTRY

  • Friends Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Frank J Vocci, Ph.D. · Friends Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2017-11-27
Completion
2017-11-27

Countries

  • United States

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 NCT02906995 on ClinicalTrials.gov