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Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

NCT01238640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2012-07-13

Study results available
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Summary

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Conditions

  • Tobacco Dependence

Interventions

DRUG

Code STD

2 mg Single-dose of experimental nicotine product coded "STD"

DRUG

Code STE

2 mg Single-dose of experimental nicotine product coded "STE"

DRUG

Nicorette Microtab

A comparative 2 mg Single-dose of marketed tablet

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-11-30
Completion
2008-11-30

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 NCT01238640 on ClinicalTrials.gov