Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
This study has been completed.
Sponsor:
McNeil AB
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01084707
First received: March 9, 2010
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
| Condition | Intervention |
|---|---|
|
Tobacco Dependence |
Drug: Oral Nicotine Drug: Nicotine Lozenge Drug: Nicotine gum |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers. |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Primary Outcome Measures:
- Maximum Plasma Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
- Average Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)
Secondary Outcome Measures:
- Time of Maximum Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]The time at which maximum concentration is reached (Tmax)
- Minimum Plasma Concentration [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]The minimum nicotine plasma concentration during the last dosing interval (Cmin)
- Peak-Trough Fluctuation [ Time Frame: During the last dosing interval (hour 11-12 post-dose) ] [ Designated as safety issue: No ]Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)
- Nicotine Plasma Concentration [ Time Frame: One hour after start of treatment ] [ Designated as safety issue: No ]The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment
| Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oral Nicotine 24-SA
2 Self-administrations of Experimental Nicotine once every hour
|
Drug: Oral Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Other Name: generic Nicotine
|
|
Experimental: Oral Nicotine 24
2 administrations of Experimental Nicotine by study personnel once every hour
|
Drug: Oral Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Other Name: generic Nicotine
|
|
Experimental: Oral Nicotine 48
2 administrations of Experimental Nicotine by study personnel once every 30 minutes
|
Drug: Oral Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Other Name: generic Nicotine
|
|
Active Comparator: NiQuitin™ Lozenge 4 mg
1 NiQuitin™ lozenge, administered by study personnel once every hour
|
Drug: Nicotine Lozenge
Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours
Other Name: NiQuitin™
|
|
Active Comparator: Nicorette® Gum 4 mg
1 piece Nicorette® gum, chewed for 30 minutes once every hour
|
Drug: Nicotine gum
Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours
Other Name: Nicorette®
|
Detailed Description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy smokers, smoking at least 20 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.
Exclusion Criteria:
- 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.
- Prior regular use of nicotine mouth spray
Contacts and Locations More Information
No publications provided
| Responsible Party: | Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ) |
| ClinicalTrials.gov Identifier: | NCT01084707 History of Changes |
| Other Study ID Numbers: | NICTDP1066-A6431117, 2008-006279-65 |
| Study First Received: | March 9, 2010 |
| Results First Received: | April 16, 2010 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
|
Smoking Cessation, Nicotine pharmacokinetics |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013