MedDataX Logo

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

NCT ID: NCT01238640

Last Updated: 2012-07-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Dependence

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Smoking Cessation Nicotine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Code STD

An experimental 2 mg nicotine product coded "STD"

Group Type EXPERIMENTAL

Code STD

Intervention Type DRUG

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

Code STE

An experimental 2 mg nicotine product coded "STE"

Group Type EXPERIMENTAL

Code STE

Intervention Type DRUG

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

Nicorette Microtab

A comparative 2 mg marketed nicotine product called Nicorette Microtab

Group Type ACTIVE_COMPARATOR

Nicorette Microtab

Intervention Type DRUG

A comparative 2 mg Single-dose of marketed tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Code STD

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

Intervention Type DRUG

Code STE

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

Intervention Type DRUG

Nicorette Microtab

A comparative 2 mg Single-dose of marketed tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Not marketed Not marketed Nicorette® Microtab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy subjects, smoking at least 10 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McNeil AB Clinical Pharmacology R&D

Lund, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-002788-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1072

Identifier Type: -

Identifier Source: org_study_id