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This is an explorative study comparing new prototypes of Nicotine Replacement Products with NicoretteĀ® gum.
This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 Short, no buffer | Experimental | Nicotine / not yet marketed |
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| A2 Short, low buffer | Experimental | Nicotine / not yet marketed |
|
| A3 Short, high buffer | Experimental | Nicotine / not yet marketed |
|
| B1 Long, no buffer | Experimental | Nicotine / not yet marketed |
|
| B2 Long, low buffer | Experimental | Nicotine / not yet marketed |
|
| B3 Long, high buffer | Experimental | Nicotine / not yet marketed |
|
| R = Nicotine Gum |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration | The maximum observed nicotine concentration in plasma (Cmax) | Baseline to 10 hours post-dose |
| Area under the Curve | The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUCā) | 10 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration | Time to Maximum Concentration (Tmax) | 10 hours post-dose |
| Residual Nicotine | The amount of residual nicotine in the product after being chewed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kruse, PhD | McNeil AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Unit, Clinical Research and Trial Centre | Lund | SE-221 85 | Sweden |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Active Comparator |
NicoretteĀ® Gum |
|
|
| Nicotine Gum | Drug | Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes. |
|
|
| 30 minutes |
| Dissolution Time | Actual time required for oral dissolution of new NRT products following product administration | 10 hours post-dose |
| D001519 | Behavior |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |