A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers

December 18, 2017 updated by: GlaxoSmithKline

A Single-Dose, Open-Label, Three-way Crossover Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Chinese Male Healthy Adult Smokers

This is a randomized, open-label, single-dose, three-period, crossover, single-center comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult participants with a history of cigarette smoking. The participants will be admitted to the investigational clinic at least 38 hours before dosing and will remain domiciled until the completion of all study procedures at approximately 24 hours after dosing. Three toothpastes (one is commercial non-medicated non-nicotine containing chewing gum and other two are nicotine containing gums) will be provided across the 3 treatment periods. During each of the 3 treatment periods, participants will be under supervision in a non-smoking area and will abstain from smoking.There will be a total of at least 7 days and not more than 10 days (clinical furlough period) between treatment periods. Twenty (20) blood samples will be collected for pharmacokinetic (PK) analysis at baseline and multiple time points following study drug administration. The trial duration will be approximately 49 days and up to 55 days from screening to study end including the screening period.

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.

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.
45

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, 100032
        • GSK Investigational Site

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments and the study.
  • Chinese male participants between 18 and 45 years of age (inclusive) in general good physical health as judged by the Investigator.
  • Normal vital signs as follows:
  • Oral body temperature between 35.0 and 37.5 ºC (95 and 99.5 F) inclusive
  • Supine systolic blood pressure between 90 and 140 mmHg inclusive
  • Supine diastolic blood pressure between 55 and 90 mmHg inclusive
  • Pulse rate between 50 and 100 beats per minute (bpm) inclusive
  • History of cigarette smoking of at least 10 cigarettes per day continuously for the past 3 months prior to screening.
  • Body weight ≥ 50 kg, Body Mass Index (BMI) between 19 and 28 at screening.
  • Ability to communicate and comply with all study requirements including the study specific chewing and swallowing procedures.

Exclusion Criteria:-

  • Use of other investigational drugs within 30 days or 10 half-lives of enrollment, whichever is longer.
  • History of or known hypersensitivity to the study drug or excipients.
  • Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.
  • Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance.
  • History of malignancy or neoplastic disease of any organ system treated or untreated, orthostatic hypotension, cardiovascular disease, stroke, TIA, fainting or blackouts, clinically significant metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders.. within the past 5 years prior to screening.
  • Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric, other diseases or other clinically significant laboratory findings at screening.
  • Participant has used any medication within two weeks before first scheduled study drug administration or within less than 10 times the elimination half-life of the respective drug.
  • Unable to comply with the chewing and/or swallowing rhythm requirements (> 5% deviation of the total counts over 30 minutes) after trying either one of the two training sessions for 3 times.
  • CO > 12 ppm after at least 38 hours confinement period in clinics prior to first dosing.
  • Participants reports consumption of any drug metabolizing enzyme inducing or inhibiting aliments, evidence of current alcohol abuse or reports consumption exceeding 35 g of pure alcohol per day.
  • Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis, positive results in any of the virology tests for Human immunodeficiency virus (HIV)-Ab, Hepatitis C virus (HCV)-Ab, Surface antigen of the hepatitis B virus (HBs-Ag), and Tp-Ab.
  • Participation in a previous clinical study with or without another investigational product and with ~470 ml blood drawn, or blood donation within the last 3 months prior to screening or previous enrollment into the current study.
  • Vulnerable individual
  • Inability to be venipuncture and/or tolerate venous access, unwilling to accept slight irritation of the throat and increased salivation due to nicotine gum administration.
  • Unable or unwilling to discontinue the use or consumption of cigarette smoking, any nicotine containing products, Oral, local or topical pharmaceutical agents, consumption of caffeine/theophylline - containing products, grapefruit, Seville orange, orange, lemon, lime, apple, and pineapple, performance of unaccustomed strenuous physical exercise.

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.
Other: Treatment A:Treatment B:Treatment C
Participants will be administered with Treatment A(Nicorette 2 mg coated mint gum) followed by Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Other: Treatment A: Nicorette 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicorette
Other: Treatment B: Nicotinell 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicotinell
Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
Other: Treatment B:Treatment C:Treatment A
Participants will be administered with Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment A(Nicorette 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Other: Treatment A: Nicorette 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicorette
Other: Treatment B: Nicotinell 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicotinell
Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
Other: Treatment C:Treatment A:Treatment B
Participants will be administered with Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment A(Nicorette 2 mg coated mint gum) followed by Treatment B (Nicotinell 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Other: Treatment A: Nicorette 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicorette
Other: Treatment B: Nicotinell 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicotinell
Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
Other: Treatment A: Treatment C:Treatment B
Participants will be administered with Treatment A (Nicorette 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment B (Nicotinell 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Other: Treatment A: Nicorette 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicorette
Other: Treatment B: Nicotinell 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicotinell
Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
Other: Treatment B:Treatment A: Treatment C
Participants will be administered with Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment A (Nicorette 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Other: Treatment A: Nicorette 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicorette
Other: Treatment B: Nicotinell 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicotinell
Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
Other: Treatment C:Treatment B:Treatment A
Participants will be administered with Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment A (Nicorette 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Other: Treatment A: Nicorette 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicorette
Other: Treatment B: Nicotinell 2 mg coated mint gum
Participants will be administered with 2 mg coated mint gum of Nicotinell
Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell

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
Area under the curve from time zero to last sampling time [AUC(0-t)]
Time Frame: 2 days
AUC(0-t) will be calculated using the trapezoidal rule. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]
Time Frame: 2 days
The area under the plasma concentration versus time curve will be calculated from time 0 to infinity where AUC = AUClast + Clast/λz Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Maximum plasma concentration (Cmax)
Time Frame: 2 days
Cmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Time to reach maximum plasma concentration (Tmax)
Time Frame: 2 days
Tmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Termination rate constant (Lambda_z)
Time Frame: 2 days
Lambda_z will be computed as the slope of the regression line of ln (C(t)) on time. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Elimination half life (t1/2)
Time Frame: 2 days
T1/2 will be computed as T1/2 = 0.693/ λz. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Systemic clearance (CL/F)
Time Frame: 2 days
CL/F will be calculated as the Dose/AUCinf, where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days
Apparent volume of distribution (Vd/F)
Time Frame: 2 days
Vd/F will be determined by the following equation: Vz/F = Dose/(lambda_z · AUCinf), where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
2 days

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.
GlaxoSmithKline

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.
March 11, 2016

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.
June 12, 2016

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.
June 12, 2016

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).
February 18, 2016

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.
February 18, 2016

First Posted (Estimate)

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.
February 23, 2016

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.
December 19, 2017

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.
December 18, 2017

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.
December 1, 2017

More Information

Terms related to this study

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.
  • 204979

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