Smoking CessationPhase 1NCT03432273
Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges
A Phase 1 study testing Nicotine lozenge in people with Smoking Cessation, run by Fertin Pharma A/S at 1 site in South Africa.
Trial summary
The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Africa
- Study dates
- 19 Feb 2018to 27 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written consent given for participation in the study.
- Healthy males and females, 18 to 55 years (inclusive) at screening.
- Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
- Body mass not less than 50 kg.
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
- Females, if:
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- Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: in postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
- Of childbearing potential, the following conditions are to be met:
- Negative pregnancy test
- If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term.
- Not lactating
- Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study Examples of reliable methods of contraception include oral (documented that the dose has been stable for at least one month before the first intake of IMP), injectable or implantable contraceptives and non-hormonal intrauterine device.
- In this study the concomitant use of hormonal contraceptives is allowed. Other methods, if considered by the investigator as reliable, will be accepted.
- History of cigarette smoking of at least 10 cigarettes per day continuously for the past 3 months prior to screening and smokes first cigarette in more than 30 minutes after waking up in the morning.
- No use of any tobacco or nicotine-containing products within 21 days of the first dose except cigarettes.
- Have no interest in quitting smoking.
- Have accepted to refrain from smoking for the duration of the study periods.
- Exhaled CO concentration > 10 ppm at screening.
- Successfully completed the dissolution training session prior to randomization.
- Ability to communicate and comply with all study requirements including the study specific method of administration for the nicotine lozenges.
Who cannot join
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any IMP substance.
- Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females or evidence of excessive alcohol use as indicated by an alcohol breathalyzer test result ≥ 0.01%.
- Regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
- In this study the concomitant use of hormonal contraceptives is allowed.
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- Expired CO levels greater than 10 ppm in the morning prior to dosing.
- History of esophagitis, gastritis, peptic ulcer, gastro-esophageal reflux, gastrointestinal bleeding, rectal bleeding or other clinically significant gastrointestinal abnormalities within past 3 months.
- History of cardiovascular disease such as uncontrolled hypertension, myocardial infarction, stroke or transient ischemic attack within the past 6 months prior to screening, congestive heart failure, angina pectoris, and arrhythmia.
- Evidence of vasospastic disease (i.e., Buerger's disease) on medical history and physical examination.
- Unable or unwilling to abstain from methylxanthines for 72 hours pre-dose.
- Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin, whichever is the longer) before administration of IMP in this study, at the discretion of the investigator.
- Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
- A major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity or allergy to the IMP or its excipients or any related medication.
- History of bronchial asthma or any other bronchospastic disease.
- History of convulsions.
- History of porphyria.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP.
- Diagnosis of hypotension made during the screening period.
- Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
- Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
- Positive testing for HIV, Hepatitis B and Hepatitis C.
- Positive urine screen for drugs of abuse. In case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the investigator.
- Positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)
Bloemfontein, 9301
About this study
Official title: A Single-Center, Single-Dose, Open-Label, Laboratory-Blind, Randomized, Two-Period Crossover Study to Determine the Bioequivalence of Two Nicotine Resinate Lozenge Formulations Containing Nicotine 2 mg in up to 42 Healthy Male and Female Smokers Under Fasting Conditions
The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine lozenge
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine lozengeDrug
Nicotine mint lozenge, 2 mg
Nicotine lozengeDrug
NiQuitin mint lozenge, 2 mg
| Study group | Role | What they receive |
|---|---|---|
| Nicotine 2 mg mint lozenges | Experimental | Not described Receives: Drug: Nicotine lozenge |
| NiQuitin 2 mg mint lozenges | Active comparator | Not described Receives: Drug: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration (Cmax)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
AUC0-t
Area under the plasma concentration versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
Secondary outcomes (5)
Tmax
Time to maximum observed plasma concentration (tmax)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
AUC0-inf
Area under the plasma concentration versus time curve, with extrapolation to infinity (AUC0-inf)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
λz
Terminal elimination rate constant (λz)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
t½.z
Apparent terminal elimination half-life (t½.z)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
kel
Apparent terminal elimination rate constant (kel)
Measured: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start19 Feb 2018
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertin Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yolandi Swart, Dr., Principal investigator, PAREXEL (South Africa)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432273
- Sponsor's protocol ID
- F-ZA113
- Status last verified
- Aug 2018
- First submitted
- 1 Feb 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Dose, Open-Label, Laboratory-Blind, Randomized, Two-Period Crossover Study to Determine the Bioequivalence of Two Nicotine Resinate Lozenge Formulations Containing Nicotine 2 mg in up to 42 Healthy Male and Female Smokers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03432273
- Acronym / sponsor ID
- F-ZA113
- Conditions
- Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fertin Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine 2 mg mint lozenges | Experimental | Drug: Nicotine lozenge |
| NiQuitin 2 mg mint lozenges | Active comparator | Drug: Nicotine lozenge |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Written consent given for participation in the study.
- Healthy males and females, 18 to 55 years (inclusive) at screening.
- Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
- Body mass not less than 50 kg.
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
Key exclusion criteria (26 listed)
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any IMP substance.
- Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females or evidence of excessive alcohol use as indicated by an alcohol breathalyzer test result ≥ 0.01%.
- Regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
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 lozengeNicotine mint lozenge, 2 mg | Drug | Nicotine 2 mg mint lozenges |
| Nicotine lozengeNiQuitin mint lozenge, 2 mg | Drug | NiQuitin 2 mg mint lozenges |
Primary outcome
Cmax
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
Maximum observed plasma concentration (Cmax)
AUC0-t
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
Area under the plasma concentration versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t)
5 secondary outcomes
Tmax
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
AUC0-inf
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
λz
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
t½.z
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
kel
Time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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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.
Yolandi Swart, Dr. principal investigator
PAREXEL (South Africa)
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 lozenge in people with Smoking Cessation, run by Fertin Pharma A/S at 1 site in South Africa.
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 20 inclusion and 26 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 9 Aug 2018. 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 South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (time frame: Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours). The study lists 2 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 9 Aug 2018.