Single-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:
NCT01084603
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 single-dose of nicotine.
| Condition | Intervention |
|---|---|
|
Tobacco Dependence |
Drug: Oral Nicotine Drug: NiQuitinTM Nicotine Lozenge Drug: Nicorette® 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: | Single-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 12 hours after start of administration ] [ 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)
- Bioavailability [ Time Frame: 12 hours ] [ Designated as safety issue: No ]A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).
Secondary Outcome Measures:
- Nicotine Plasma Concentration [ Time Frame: During 10 minutes after start of administration ] [ Designated as safety issue: No ]Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
- Time of Maximum Concentration [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]The time at which maximum concentration is reached (Tmax)
- Terminal Elimination Rate Constant [ Time Frame: During 12 hours after start of administration ] [ Designated as safety issue: No ]The terminal nicotine elimination rate constant (Lamda z)
- Released Nicotine [ Time Frame: After 30 minutes' chewing ] [ Designated as safety issue: No ]The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing
| Enrollment: | 45 |
| Study Start Date: | March 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oral Nicotine 1
One oral administration of 1 mg nicotine
|
Drug: Oral Nicotine
A new l mg oral nicotine product
Other Name: Experimental nicotine 1 mg
|
|
Experimental: Oral Nicotine 2
Two oral administrations of 1 mg nicotine
|
Drug: Oral Nicotine
A new l mg oral nicotine product
Other Name: Experimental nicotine 1 mg
|
|
Experimental: Oral Nicotine 4
Four oral administrations of 1 mg nicotine
|
Drug: Oral Nicotine
A new l mg oral nicotine product
Other Name: Experimental nicotine 1 mg
|
|
Active Comparator: NiQuitinTM Nicotine Lozenge 4 mg
One 4 mg marketed nicotine lozenge
|
Drug: NiQuitinTM Nicotine Lozenge
A marketed 4 mg Nicotine lozenge
Other Name: NiQuitinTM lozenge
|
|
Active Comparator: Nicorette® Gum 4 mg
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Drug: Nicorette® Nicotine Gum
A marketed 4 mg Nicotine Gum
Other Name: Nicorette® gum
|
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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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 15 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 months preceding the first dose of study medication.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ) |
| ClinicalTrials.gov Identifier: | NCT01084603 History of Changes |
| Other Study ID Numbers: | NICTDP1065/A6431116, 2008-006280-36 |
| 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 June 18, 2013