Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01702532 | Nicotine Mouth Film for Craving Relief. | PHASE3 | COMPLETED | 320 | — | — | Sep 1, 2012 | Dec 1, 2012 | Jan 30, 2014 | 2 | United States |
| NCT01669122 | Pharmacokinetic Study of 4 mg Nicotine Lozenge. | PHASE2 | COMPLETED | 40 | — | — | Jun 1, 2012 | Aug 1, 2012 | Jan 22, 2015 | 1 | India |
| NCT01476202 | Provoked Craving Relief Study by NRT | PHASE2 | COMPLETED | 120 | — | — | Nov 1, 2011 | Jan 1, 2012 | Sep 30, 2013 | 1 | United States |
| NCT01847443 | Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations | PHASE1 | COMPLETED | 84 | — | — | May 1, 2013 | Jun 1, 2013 | Apr 11, 2014 | 1 | United Kingdom |
| NCT01536704 | Nicotine Lozenge Bioequivalence Study | PHASE1 | COMPLETED | 50 | — | — | Jul 1, 2011 | Aug 1, 2011 | Apr 26, 2013 | 1 | United States |
Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Cmax for 2 mg test was compared with 2 mg reference gum
Cmax for 4 mg test was compared with 4 mg reference gum
AUC(0-t) was evaluated using the trapezoid rule.
Cmax was depicted from plasma concentration of nicotine.
| Arm | Type | Description |
|---|---|---|
| Nicotine Mouth Film | EXPERIMENTAL | mint nicotine mouth film, buccal administration |
| Nicotine Lozenge | ACTIVE_COMPARATOR | nicotine lozenge, buccal administration |
| Prototype 1 | EXPERIMENTAL | 4mg nicotine lozenge administered orally as a single dose treatment per subject |
| Prototype 2 | EXPERIMENTAL | 4mg nicotine lozenge administered orally as a single dose treatment per subject |
| Prototype 3 | EXPERIMENTAL | 4mg nicotine lozenge administered orally as a single dose treatment per subject |
| Reference Therapy | ACTIVE_COMPARATOR | 4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject. |
| Nicotine mouth strip | EXPERIMENTAL | single dose |
| nicotine gum | ACTIVE_COMPARATOR | single dose |
| Test nicotine gum (2 mg) | EXPERIMENTAL | A single dose of Nicotine Mint Gum (2 mg) to be chewed. |
| Test nicotine gum (4 mg) | EXPERIMENTAL | A single dose of Nicotine Mint Gum (4 mg) to be chewed. |
| Reference nicotine gum (2 mg) | ACTIVE_COMPARATOR | A single dose of reference nicotine gum (2 mg) to be chewed. |
| Reference nicotine gum (4 mg) | ACTIVE_COMPARATOR | A single dose of reference nicotine gum (4 mg) to be chewed. |
| Test nicotine lozenge (2 mg) | EXPERIMENTAL | 2 mg test nicotine lozenge to be chewed. |
| Test nicotine lozenge (4 mg) | EXPERIMENTAL | 4 mg test nicotine lozenge to be chewed. |
| Reference nicotine lozenge (2 mg) | ACTIVE_COMPARATOR | 2 mg reference nicotine lozenge to be chewed. |
| Reference nicotine lozenge (4 mg) | ACTIVE_COMPARATOR | 4 mg reference nicotine lozenge to be chewed. |
| Name | Type | Description |
|---|---|---|
| Nicotine | DRUG | Comparison of different dosage forms of nicotine |
| Nicotine (2 mg) | DRUG | 2 mg nicotine gum in two formulations |
| Nicotine (4 mg) | DRUG | 4 mg nicotine gum in two formulations |
Inclusion Criteria: * BMI within the range of 19-35 kg/m2; * Current cigarette smokers who have smoked regularly daily for at least a year, * Participants who smoke their first cigarette more than 30 minutes after waking up Exclusion Criteria: * Known or suspected intolerance or hypersensitivity ...