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Nicotine Prototype Mini lozenge · 2 trials · 1 indication
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC\[0-inf\]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
| Arm | Type | Description |
|---|---|---|
| Test Product | EXPERIMENTAL | Participants will receive a single Nicotine Prototype Mini lozenge (2mg) by oral/buccal route of administration. |
| Reference Product | ACTIVE_COMPARATOR | Participants will receive a single Nicorette Mini lozenge (2 mg) by oral/buccal route of administration. |
| Name | Type | Description |
|---|---|---|
| Nicotine Prototype Mini lozenge | DRUG | A single dose of a prototype nicotine 2mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved. |
| Nicorette Mini Lozenge | DRUG | A single dose of a 2 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participants who are willing and able to comply with scheduled visits, treatment pl...
Nicotine Prototype Mini lozenge is an investigational small molecule being developed for Tobacco Use Disorder. It is a nicotine replacement therapy designed to help smokers manage nicotine withdrawal and cravings. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Nicotine Prototype Mini lozenge is being developed by GSK plc, a global pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's bioequivalence to existing nicotine lozenge products in healthy smokers.
Nicotine Prototype Mini lozenge is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, with a total of 83 participants enrolled. The drug remains investigational and has not received FDA approval for any indication.
Nicotine Prototype Mini lozenge has completed two Phase 1 trials. NCT03541044 enrolled 46 healthy smokers in the United States to assess bioequivalence of two nicotine lozenges under fasting conditions. NCT03543137 enrolled 37 healthy smokers to compare the 4mg prototype mini lozenge to the reference Nicorette product.
Nicotine Prototype Mini lozenge delivers nicotine to the body as a replacement therapy for Tobacco Use Disorder. By providing a controlled dose of nicotine, it helps reduce withdrawal symptoms and cravings associated with smoking cessation. The lozenge is designed to be bioequivalent to existing nicotine replacement products.
Nicotine Prototype Mini lozenge is not the same as Nicorette, but it is being studied as a potential generic or alternative version. Clinical trials compare the prototype lozenge to Nicorette as a reference product to assess bioequivalence. The prototype is an investigational formulation developed by GSK.