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Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

NCT01238627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-07-10

No results posted yet for this study

Summary

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

Conditions

  • Tobacco Dependence

Interventions

DRUG

Nicotine Sublingual Tablet Mint (NSTM)

A single dose of an experimental NSTM, with a 36-hour washout between visits

DRUG

Marketed Nicotine Tablet

A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-11-30
Completion
2007-11-30

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 NCT01238627 on ClinicalTrials.gov