Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicorette Strongmint lozenge · 1 trial · 1 indication
The maximum observed plasma concentration (Cmax)
Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs
AUCt is defines as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).
The area under the plasma concentration versus time curves from start of drug administration until infinity.
The rate at which the drug is removed from the body system.
The time taken for the nicotine plasma concentration to fall to half its original value.
| Arm | Type | Description |
|---|---|---|
| Nicorette Strongmint lozenge 4mg | EXPERIMENTAL | A single dose of one nicotine 4 mg lozenge will be administrated orally to slowly dissolve in the mouth for nicotine absorption via the buccal mucosa. |
| Niquitin Minimint lozenge 4mg | ACTIVE_COMPARATOR | A single dose of one nicotine 4mg lozenge will be administrated orally to slowly dissolve in the mouth for nicotine absorption via the buccal mucosa. |
| Name | Type | Description |
|---|---|---|
| Nicorette Strongmint lozenge 4 mg | DRUG | A single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth. |
| Niquitin MiniMint lozenge 4 mg | DRUG | A single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth. |
Inclusion Criteria: 1. Male and/or female subjects 18 to 45 years of age, inclusive, and being verified "Healthy". ("Healthy" is defined as absence of any diseases or abnormalities on the basis of physical examination, standard clinical laboratory and instrumental examinations performed at the scre...
Nicorette Strongmint lozenge is used for tobacco dependence, helping adult smokers who are motivated to quit. It is a nicotine replacement therapy lozenge. The 4 mg strength is the subject of a completed Phase 1 bioequivalence study in healthy adult smokers.
Nicorette Strongmint lozenge is made by Johnson & Johnson, which trades under the ticker JNJ. The company is the developer of the product.
Nicorette Strongmint lozenge has been studied in a Phase 1 clinical trial. That trial is completed, and no active trials are currently listed. It is a nicotine replacement therapy product rather than a novel investigational drug.
Nicorette Strongmint lozenge was evaluated in the completed Phase 1 trial NCT03130179, titled A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit. The trial enrolled 244 participants in Russia, was randomized, actively controlled, and included healthy volunteers aged 18 years and older.