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Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers

NCT03259607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-01-03

No results posted yet for this study

Summary

This is a research study to verify the same effectiveness and safety profile for the test products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products, Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized mode. This verification is done in a so-called bioequivalence study, which means that the same amount of the same active substance (nicotine), in the same dosage form, for the same route of administration, and meeting the same or comparable standards is performed.

During the study visits, blood samples will be drawn to measure the level of the substance in the blood to verify that the two test products are comparable to the reference products.

Tolerability of the treatments will be evaluated based on reported and observed adverse events.

Conditions

  • Tobacco Dependence

Interventions

DRUG

Nicorette Extra Mint 2 mg Gum

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

DRUG

Nicorette Mint 2 mg Gum

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

DRUG

Nicorette Extra Mint 4mg Gum

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

DRUG

Nicorette Mint 4 mg Gum

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

Sponsors & Collaborators

  • Janssen (China) Research & Development Center

    collaborator UNKNOWN

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Shi Aixin, M. Pharm · BeiJing Hospital, No.1, Beijing, China.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2017-12-25
Completion
2018-01-09

Countries

  • China

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 NCT03259607 on ClinicalTrials.gov