Tobacco Use DisorderPhase 1NCT03541044
A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers
A Phase 1 study testing Nicotine Prototype Mini lozenge and Nicorette Mini Lozenge in people with Tobacco Use Disorder, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 2 mg) in healthy smokers under fasting conditions. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Nicotine Prototype Mini lozenge and Nicorette Mini Lozenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 24 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy participants which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure, respiratory rate, oral body temperature and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- Body Mass Index (BMI) of 19 to 27 Kilogram per meter square (kg/m2), inclusive; and a total body weight >50 kg (110 pounds [lbs]).
- Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female participants who are not of childbearing potential must meet at least one of the following criteria: a) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state. b) Have undergone a documented hysterectomy and/or bilateral oophorectomy.
- Participant admits to having smoked commercially available cigarettes daily for the preceding 12 months and to routinely smoking his or her first cigarette more than 30 minutes upon awakening. Brief periods of non-smoking (e.g. due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the PI (Principal Investigator).
Who cannot join
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to first dose and during study participation.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the Participant inappropriate for entry into this study.
- Pregnant female Participants.
- Breastfeeding female Participants.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Show all 23Show fewer
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- Participant has used any nicotine replacement therapy within 21 days prior to the first study session.
- Participant has used chewing tobacco, tobacco products or electronic cigarettes other than cigarettes within 21 days of Visit 1.
- Use of prescription or non-prescription drugs and dietary supplements within two weeks or 5 half-lives, whichever is longer, prior to the first dose of investigational product until the end of the study. Allowed treatments are: Systemic contraceptives and hormone replacement therapy, as long as female Participant is on stable treatment for at least 3 months and continues treatment throughout the study. Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- A positive urine drug screen for THC, amphetamine, cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA)/ecstasy, methamphetamine, or opiates; and urine alcohol testing during screening or baseline testing.
- Participant is unwilling to abstain from tobacco or nicotine-containing product use during each study session (from start of baseline to the completion of the last PK blood sampling). CO measurement immediately prior to randomization (first treatment session) and dosing (second treatment session) should be ≤ 10 parts per million (ppm) for the Participant to be dosed.
- Participant ingests more than 5 cups of coffee or tea a day (or equivalent xanthine consumption using other products).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
- A medical history that, in the opinion of the investigator, might jeopardize the safety of the Participant, e.g., recent myocardial infarction or cerebrovascular accident (i.e., within 12 weeks prior to the first study session), severe cardiac arrhythmia, history of seizures, orthostatic hypotension, cardiovascular disease, stroke, or TIA.
- A medical history, which, in the opinion of the investigator, might impact the validity of the study results, may require treatment, or make the Participant unlikely to finish the study.
- Oral surgery within 4 weeks of dosing, dental work or extractions within 2 weeks of dosing, or presence of any clinically significant (as determined by the principal investigator or designee) oral pathology including lesions, sores or inflammation.
- Diagnosis of long QT syndrome or QTc > 460 msec for males and > 470 msec for females at screening.
- Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance including, but not limited to, any of the following: i)Presence of active oesophagitis, oral or pharyngeal ulceration, inflammation, gastritis, gastric ulcer or peptic ulcer or other diseases; ii) Presence of gum disease, xerostomia, dentures or any dental work that could affect the conduct of the study as determined by the investigator or designee; iii) Renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine or urea or the presence of clinically significant abnormal urinary constituents (e.g. albuminuria). Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance; iv) Ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found and are clinical ly relevant: aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), Alanine Aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT), γ-glutamyl transpeptidase (γGGT), alkaline phosphatase, bilirubin or CK. Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance; v) History or clinical evidence at screening of pancreatic injury or pancreatitis; vi) Evidence of urinary obstruction or difficulty in voiding at screening; vii) History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases. viii) Clinically relevant chronic or acute infectious illnesses or febrile infections within 2 weeks prior to start of the study (enrollment). ix) Other clinically significant laboratory findings in the opinion of the Investigator at screening.
- A positive serum Hepatitis B surface antigen, Hepatitis C antibodies, or human immunodeficiency virus (HIV) test result.
- Blood: a) Has donated or experienced significant blood loss (470 mL) within 56 days of Visit b) Hemoglobin value < 12.0 grams per deciliter (g/dL).
- Participants who have previously been enrolled in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose Bioequivalence Study of a 2 mg Prototype Mini Nicotine Lozenge vs 2 mg Nicotine Mini Lozenge (Nicorette Minis) Healthy Smokers Under Fasting Conditions
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 2 mg) in healthy smokers under fasting conditions.
Read the detailed description
This study will be a single center, randomized, open label, single dose, two-way crossover in healthy smokers that smoke their first cigarette more than 30 minutes of waking. This study will consist of following Visits: Visit 1 (Screening), Visit 2 (Study Period 1), followed by a Washout period and Visit 3 (Study Period 2). Each participant will be treated with a single dose of the two study treatments (test and reference) in a randomized sequence. Participants will be confined in the study facility for approximately 60 hours during each study session (for 36 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. Participants are to abstain from smoking during the confinement periods and be subject to random measurements of expired carbon monoxide (CO) to confirm abstinence. The CO levels must be ≤10 parts per million (ppm) throughout the study session. There will be at least 5-day and not more than 7-day clinical furlough period between treatment periods. For each treatment period, the clinical confinement period with restriction of smoking is at least 36 hours prior to dosing.
- Conditions
- Tobacco Use Disorder
- Being tested
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Prototype Mini lozengeDrug
A single dose of a prototype nicotine 2mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
Nicorette Mini LozengeDrug
A single dose of a 2 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Participants will receive a single Nicotine Prototype Mini lozenge (2mg) by oral/buccal route of administration. Receives: Drug: Nicotine Prototype Mini lozenge |
| Reference Product | Active comparator | Participants will receive a single Nicorette Mini lozenge (2 mg) by oral/buccal route of administration. Receives: Drug: Nicorette Mini Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t])
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Measured: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf])
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC[0-inf]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Measured: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Maximum Observed Plasma Nicotine Concentration (Cmax)
Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Measured: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Secondary outcomes (4)
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Time of Maximum Plasma Nicotine Concentration (Tmax)
Tmax was defined as the time to maximum plasma nicotine concentration. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value.
Measured: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Half-Life (t1/2)
t1/2 was defined as apparent elimination half-life that was calculated as t1/2 = ln(2) / Kel, where Kel= elimination rate constant.
Measured: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Rate Constant for Plasma Nicotine (Kel)
kel was defined as apparent elimination rate constant for plasma nicotine that was calculated as negative of the slope of a linear regression of the log(concentration)- time for all concentrations > lower limit of quantification.
Measured: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Number of Participants With Clinically Significant Change in Laboratory Test Values
Haematological, biochemistry and urinalysis parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.
Measured: From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start18 Jun 2018
- Primary completion24 Mar 2019
- Study completion24 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541044
- Sponsor's protocol ID
- 207791
- Status last verified
- Feb 2020
- First submitted
- 17 May 2018
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Bioequivalence Study of a 2 mg Prototype Mini Nicotine Lozenge vs 2 mg Nicotine Mini Lozenge (Nicorette Minis) Healthy Smokers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03541044
- Acronym / sponsor ID
- 207791
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 24 Mar 2019 (actual)
- Study completion
- 24 Mar 2019 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Posted 12 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 2 mg) in healthy smokers under fasting conditions.
Detailed description
This study will be a single center, randomized, open label, single dose, two-way crossover in healthy smokers that smoke their first cigarette more than 30 minutes of waking. This study will consist of following Visits: Visit 1 (Screening), Visit 2 (Study Period 1), followed by a Washout period and Visit 3 (Study Period 2). Each participant will be treated with a single dose of the two study treatments (test and reference) in a randomized sequence. Participants will be confined in the study facility for approximately 60 hours during each study session (for 36 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. Participants are to abstain from smoking during the confinement periods and be subject to random measurements of expired carbon monoxide (CO) to confirm abstinence. The CO levels must be ≤10 parts per million (ppm) throughout the study session. There will be at least 5-day and not more than 7-day clinical furlough period between treatment periods. For each treatment period, the clinical confinement period with restriction of smoking is at least 36 hours prior to dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Nicotine Prototype Mini lozengeParticipants will receive a single Nicotine Prototype Mini lozenge (2mg) by oral/buccal route of administration. |
| Reference Product | Active comparator | Drug: Nicorette Mini LozengeParticipants will receive a single Nicorette Mini lozenge (2 mg) by oral/buccal route of administration. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy participants which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure, respiratory rate, oral body temperature and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- Body Mass Index (BMI) of 19 to 27 Kilogram per meter square (kg/m2), inclusive; and a total body weight >50 kg (110 pounds [lbs]).
- Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female participants who are not of childbearing potential must meet at least one of the following criteria: a) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state. b) Have undergone a documented hysterectomy and/or bilateral oophorectomy.
Key exclusion criteria (23 listed)
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to first dose and during study participation.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the Participant inappropriate for entry into this study.
- Pregnant female Participants.
- Breastfeeding female Participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Prototype Mini lozengeA single dose of a prototype nicotine 2mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved. | Drug | Test Product |
| Nicorette Mini LozengeA single dose of a 2 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved. | Drug | Reference Product |
Primary outcome
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t])
Time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf])
Time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC[0-inf]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Maximum Observed Plasma Nicotine Concentration (Cmax)
Time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
4 secondary outcomes
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Time of Maximum Plasma Nicotine Concentration (Tmax)
Time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Half-Life (t1/2)
Time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Rate Constant for Plasma Nicotine (Kel)
Time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period
Number of Participants With Clinically Significant Change in Laboratory Test Values
Time frame: From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine Prototype Mini lozenge and Nicorette Mini Lozenge in people with Tobacco Use Disorder, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t]) (time frame: 0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.