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A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.

NCT03130179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2018-07-27

No results posted yet for this study

Summary

This is a research study to verify the same effectiveness and safety profile for the test product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint lozenge (reference product), 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 products are comparable. Tolerability of the treatments will be evaluated based on reported and observed adverse events.

Conditions

  • Tobacco Dependence

Interventions

DRUG

Nicorette Strongmint lozenge 4 mg

A single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth.

DRUG

Niquitin MiniMint lozenge 4 mg

A single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth.

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elena P Mazygula, MD · "Scientific and Clinical Center of JSC "RZD"

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
2017-03-20
Primary Completion
2017-06-19
Completion
2017-06-29

Countries

  • Russia

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 NCT03130179 on ClinicalTrials.gov