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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006280-36 | EudraCT Number |
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A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nicotine 1 | Experimental | One oral administration of 1 mg nicotine |
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| Oral Nicotine 2 | Experimental | Two oral administrations of 1 mg nicotine |
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| Oral Nicotine 4 | Experimental | Four oral administrations of 1 mg nicotine |
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| NiQuitinTM Nicotine Lozenge 4 mg | Active Comparator | One 4 mg marketed nicotine lozenge |
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| Nicorette® Gum 4 mg | Active Comparator | One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nicotine | Drug | A new l mg oral nicotine product |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration | 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) | During 12 hours after start of administration |
| Bioavailability | 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). | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Plasma Concentration | Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min) | During 10 minutes after start of administration |
| Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) |
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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 Pharmacology | Lund | 222 20 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Full Safety Set |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| NiQuitinTM Lozenge |
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| Washout Period 1 |
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| Nicorette® Gum |
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| Washout Period 2 |
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| Oral Nicotine 1 |
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| Washout Period 3 |
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| Oral Nicotine 2 |
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| Washout Period 4 |
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| Oral Nicotine 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Full Safety Set |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration | 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) | ITT | Posted | Geometric Mean | Standard Deviation | (ng/ml) | During 12 hours after start of administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Nicotine 1 | 1 administration of 1 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, Sr Specialist, Clinical Research Operations | J&J Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
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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 |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| NiQuitinTM Nicotine Lozenge | Drug | A marketed 4 mg Nicotine lozenge |
|
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| Nicorette® Nicotine Gum | Drug | A marketed 4 mg Nicotine Gum |
|
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| During 12 hours after start of administration |
| Terminal Elimination Rate Constant | The terminal nicotine elimination rate constant (Lamda z) | During 12 hours after start of administration |
| Released Nicotine | The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing | After 30 minutes' chewing |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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4 administrations of 1 mg
| OG003 | NiQuitinTM Lozenge 4 mg | 1 NiQuitinTM nicotine lozenge 4 mg |
| OG004 | Nicorette® Gum 4 mg | One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes |
|
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| Secondary | Nicotine Plasma Concentration | Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min) | ITT | Posted | Geometric Mean | Standard Deviation | (h*ng/ml) | During 10 minutes after start of administration |
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| Secondary | Time of Maximum Concentration | The time at which maximum concentration is reached (Tmax) | ITT | Posted | Median | Full Range | (hours) | During 12 hours after start of administration |
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| Secondary | Terminal Elimination Rate Constant | The terminal nicotine elimination rate constant (Lamda z) | ITT | Posted | Mean | Standard Deviation | (1/hr) | During 12 hours after start of administration |
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| Secondary | Released Nicotine | The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing | ITT | Posted | Mean | Standard Deviation | (ng/ml) | After 30 minutes' chewing |
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| Primary | Bioavailability | 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). | Posted | Geometric Mean | Standard Deviation | h*ng/ml | 12 hours |
|
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| 0 |
| 41 |
| 11 |
| 41 |
| EG001 | Oral Nicotine 2 | 2 administrations of 1 mg | 1 | 42 | 11 | 42 |
| EG002 | Oral Nicotine 4 | 4 administrations of 1 mg | 0 | 43 | 24 | 43 |
| EG003 | NiQuitinTM Lozenge 4 mg | 1 NiQuitinTM nicotine lozenge 4 mg | 0 | 43 | 7 | 43 |
| EG004 | Nicorette® Gum 4 mg | One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes | 0 | 42 | 9 | 42 |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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| Hiccups | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| Throat Irritation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
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| D001519 | Behavior |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| AUC to infinity |
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