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

January 2, 2019 updated by: McNeil AB

A Single Dose, Randomized, Four Period, Fasting, Crossover Study to Assess Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Mint Gum 2 and 4 mg - in Adult Healthy Male and Female Smokers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center, randomized, single-dose open-label, cross-over study in 76 healthy males and females in total. The investigational products (IPs), i.e., Nicorette Extra Mint Gum 2 and 4 mg, and Nicorette Mint Gum 2 and 4 mg, will be given as single doses at separate treatment visits. Investigational treatments will be separated by at least 36 hours.

Blood samples for determination of nicotine will be drawn pre-dose (within 5 minutes of administering, i.e., start of chewing) and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

Used gums will be collected and analyzed to determine the amount of remaining nicotine.

Any Adverse Events (AEs) that may occur will be registered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Beijing Hospital, No.1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male subjects between the ages of 18 and 55 years, inclusive, and healthy female subjects between the ages of 18 and 45 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the Investigator or an authorized physician.
  2. Smoking of at least 10 cigarettes daily for at least one year preceding inclusion.
  3. Subjects will have a body mass index (BMI) between 19 and 25 (inclusive) kg/m2 and a body weight >50 kg.
  4. Females of childbearing potential must have a negative pregnancy test at the screening visit.
  5. Male or non-pregnant, non-lactating female agree to the contraceptive requirements including male's and female partner's use of a highly effective methods of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of the study drug).
  6. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study before participating in any study-specific procedures.
  7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

Exclusion Criteria:

  1. Use of medications other than contraceptives specified in Inclusion Criterion 4. Vitamins, dietary, and herbal supplements must be discontinued at least two days before the first dose of study medication.
  2. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, Human Immunodeficiency Virus (HIV) or syphilis.
  3. Hypersensitivity to the ingredients/components of any of the IPs.
  4. History of alcoholism, as judged by the Investigator, within the past 6 months preceding this study and/or presenting a positive respiratory alcohol test (breathalyzer) at the screening visit.
  5. History of drug abuse or presenting a positive drug screening test for psychoactive drugs and narcotic substances at screening visit.
  6. Treatment with an IP within 3 months preceding this study.
  7. Donation or loss of blood within 3 months preceding this study if the estimated lost blood volume equaled or exceeded 200 mL.
  8. Impaired chewing capability as assessed by oral examination (e.g. dentures, significant oral ulceration) or impaired salivary secretion (e.g. Sicca syndrome). Piercing of tongue and lips is considered to impair oral function.
  9. Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study.
  10. Relationship to persons involved directly with the conduct of the study (i.e. PI; Sub investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson (J&J) subsidiaries; and the families of each).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A
Nicorette Extra Mint 2 mg Gum
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.
Active Comparator: Treatment B
Nicorette Mint 2 mg Gum
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.
Experimental: Treatment C
Nicorette Extra Mint 4 mg Gum
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.
Active Comparator: Treatment D
Nicorette Mint 4 mg Gum
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax) of nicotine.
Time Frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The maximum observed plasma concentration (Cmax).
At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Area under the plasma concentration versus time curve (AUCt) from start of nicotine administration until the last measurable concentration.
Time Frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Area under the plasma concentration versus time curve (AUC∞) of nicotine.
Time Frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).
At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The extrapolated part of area under the plasma concentration versus time curve (AUC∞) of nicotine.
Time Frame: Extrapolation from 12 hours after start of drug administration until 48 hours.
The area under the plasma concentration versus time curves from start of drug administration until 48 hours (infinity).
Extrapolation from 12 hours after start of drug administration until 48 hours.
The time at which the maximum nicotine concentration (Cmax) occurs (Tmax).
Time Frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs.
At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Determination of the terminal elimination rate constant (lambda_z) for nicotine.
Time Frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The rate at which the drug is removed from the body system.
At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The plasma half-life (t1/2) of nicotine.
Time Frame: At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
The time taken for the nicotine plasma concentration to fall to half its original value.
At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.
Amount of nicotine extracted from Nicorette Mint 2 mg gums.
Time Frame: After 30 minutes of chewing.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Mint 4 mg gums.
Time Frame: After 30 minutes of chewing.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Extra Mint 2 mg gums.
Time Frame: After 30 minutes of chewing.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
After 30 minutes of chewing.
Amount of nicotine extracted from Nicorette Extra Mint 4 mg gums.
Time Frame: After 30 minutes of chewing.
The residual amount of nicotine in the chewed gums will be analyzed and subtracted from the original amount of nicotine in the gums, and summarized descriptively.
After 30 minutes of chewing.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of investigational product.
Time Frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of subjects experiencing treatment-emergent adverse events by treatment, system organ class and preferred term.
From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of investigational product - by worst-case severity.
Time Frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage (%) of subjects experiencing treatment-emergent adverse events by treatment, system organ class, preferred term and severity.
From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with common treatment-emergent adverse events (AEs) after single-dose administration of Investigational product.
Time Frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage (%) of subjects with commonly reported treatment-emergent adverse events by system organ class and preferred term.
From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of investigational product.
Time Frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse event.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class and preferred term.
From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse event.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of investigational product - by worst-case severity.
Time Frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class, preferred term and severity.
From first dose received up to 2.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-emergent serious adverse events (SAEs).
Time Frame: From first dose received up to 2.5 weeks + 30 days follow up after study completion.
Percentage (%) of subjects experiencing treatment-emergent serious adverse events.
From first dose received up to 2.5 weeks + 30 days follow up after study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McNeil AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen (China) Research & Development Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shi Aixin, M. Pharm, BeiJing Hospital, No.1, Beijing, China.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CO-160307090208-SCCT
  • 10258820NIK1001 (Other Identifier: Janssen TMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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