Tobacco DependenceNCT01238640
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
A study testing Code STD, Code STE and Nicorette Microtab 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 new oral nicotine replacement therapy products and Nicorette® microtab. 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?
- Code STD, Code STE and Nicorette Microtab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Nov 2008
- Phase
- Interventional
- 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 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 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 month preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.
Read the detailed description
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.
- Conditions
- Tobacco Dependence
- Being tested
- Code STD, Code STE, Nicorette Microtab
- Keywords
- Smoking Cessation, Nicotine
- 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.
Code STDDrug
Also called Not marketed
2 mg Single-dose of experimental nicotine product coded "STD"
Code STEDrug
Also called Not marketed
2 mg Single-dose of experimental nicotine product coded "STE"
Nicorette MicrotabDrug
Also called Nicorette® Microtab
A comparative 2 mg Single-dose of marketed tablet
| Study group | Role | What they receive |
|---|---|---|
| Code STD | Experimental | An experimental 2 mg nicotine product coded "STD" Receives: Drug: Code STD |
| Code STE | Experimental | An experimental 2 mg nicotine product coded "STE" Receives: Drug: Code STE |
| Nicorette Microtab | Active comparator | A comparative 2 mg marketed nicotine product called Nicorette Microtab Receives: Drug: Nicorette Microtab |
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 startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 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
- NCT01238640
- Sponsor's protocol ID
- NICTDP1072
- Other IDs
- 2008-002788-15, 2008
- Status last verified
- Jul 2012
- First submitted
- 9 Nov 2010
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers
- ClinicalTrials.gov ID
- NCT01238640
- Acronym / sponsor ID
- NICTDP1072
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Posted 8 Apr 2011
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 new oral nicotine replacement therapy products and Nicorette® microtab.
Detailed description
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Code STD | Experimental | Drug: Code STDAn experimental 2 mg nicotine product coded "STD" |
| Code STE | Experimental | Drug: Code STEAn experimental 2 mg nicotine product coded "STE" |
| Nicorette Microtab | Active comparator | Drug: Nicorette MicrotabA comparative 2 mg marketed nicotine product called Nicorette Microtab |
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 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 month 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 |
|---|---|---|
| Code STDAlso: Not marketed2 mg Single-dose of experimental nicotine product coded "STD" | Drug | Code STD |
| Code STEAlso: Not marketed2 mg Single-dose of experimental nicotine product coded "STE" | Drug | Code STE |
| Nicorette MicrotabAlso: Nicorette® MicrotabA comparative 2 mg Single-dose of marketed tablet | Drug | Nicorette Microtab |
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- 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.
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 Code STD, Code STE and Nicorette Microtab 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 13 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?
Yes. Results are posted in the registry (first posted 8 Apr 2011). 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?
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 13 Jul 2012.