Tobacco DependenceNCT01238627
Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
A study testing Nicotine Sublingual Tablet Mint (NSTM) and Marketed Nicotine Tablet in people with Tobacco Dependence, run by McNeil AB at 1 site in Sweden.
Trial summary
The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Nicotine Sublingual Tablet Mint (NSTM) and Marketed Nicotine Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Nov 2007
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and Body Mass Index (BMI) between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Who cannot join
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg - A Study in Healthy Smokers
The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.
Read the detailed description
The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine Sublingual Tablet Mint (NSTM), Marketed Nicotine Tablet
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Sublingual Tablet Mint (NSTM)Drug
Also called Not marketed
A single dose of an experimental NSTM, with a 36-hour washout between visits
Marketed Nicotine TabletDrug
Also called Nicorette® Microtab
A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Sublingual Tablet Mint (NSTM)-2 | Experimental | Experimental 2 mg NSTM Receives: Drug: Nicotine Sublingual Tablet Mint (NSTM) |
| Microtab-2 | Active comparator | 2 mg Nicotine tablet Receives: Drug: Marketed Nicotine Tablet |
| NSTM-4 | Experimental | Experimental 4 mg Nicotine Sublingual Tablet Mint Receives: Drug: Nicotine Sublingual Tablet Mint (NSTM) |
| Microtab-4 | Active comparator | 2 x 2 mg Nicotine tablet Receives: Drug: Marketed Nicotine Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)
Measured: During 10 hours post-dose
Area Under the Curve (AUC)(0-t)
Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).
Measured: During 10 hours post-dose
AUC(0-∞)
AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).
Measured: 10 hours post-dose
Secondary outcomes (1)
Product Dissolution Time
Product Dissolution Time is the time from administration until the investigational products were completely dissolved.
Measured: During 10 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238627
- Sponsor's protocol ID
- NICTDP1064-A6431115
- Other IDs
- 2007-002180-27
- Status last verified
- Jul 2012
- First submitted
- 9 Nov 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg - A Study in Healthy Smokers
- ClinicalTrials.gov ID
- NCT01238627
- Acronym / sponsor ID
- NICTDP1064-A6431115
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 10 Nov 2010 (estimated)
- 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 this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.
Detailed description
The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational products will be given as single doses at separate visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at 5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete product dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. The trial is open in the sense that subjects and study personnel will be aware of what product is administered at a given visit. However, the treatment labels will not be known by the people performing bioanalysis or analyzing pharmacokinetic data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine Sublingual Tablet Mint (NSTM)-2 | Experimental | Drug: Nicotine Sublingual Tablet Mint (NSTM)Experimental 2 mg NSTM |
| Microtab-2 | Active comparator | Drug: Marketed Nicotine Tablet2 mg Nicotine tablet |
| NSTM-4 | Experimental | Drug: Nicotine Sublingual Tablet Mint (NSTM)Experimental 4 mg Nicotine Sublingual Tablet Mint |
| Microtab-4 | Active comparator | Drug: Marketed Nicotine Tablet2 x 2 mg Nicotine tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and Body Mass Index (BMI) between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (2 listed)
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.
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 Sublingual Tablet Mint (NSTM)Also: Not marketedA single dose of an experimental NSTM, with a 36-hour washout between visits | Drug | NSTM-4, Nicotine Sublingual Tablet Mint (NSTM)-2 |
| Marketed Nicotine TabletAlso: Nicorette® MicrotabA single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits | Drug | Microtab-2, Microtab-4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: During 10 hours post-dose
Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)
Area Under the Curve (AUC)(0-t)
Time frame: During 10 hours post-dose
Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).
AUC(0-∞)
Time frame: 10 hours post-dose
AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).
1 secondary outcome
Product Dissolution Time
Time frame: During 10 hours post-dose
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 10 Jul 2012.
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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.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Sublingual Tablet Mint (NSTM) and Marketed Nicotine Tablet in people with Tobacco Dependence, run by McNeil AB at 1 site in Sweden.
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 3 inclusion and 2 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 10 Jul 2012. 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 Sweden. 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.
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?
Maximum Observed Plasma Concentration (Cmax) (time frame: During 10 hours post-dose). 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 10 Jul 2012.