Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicorette Mint Gum · 1 trial · 1 indication
The maximum observed plasma concentration (Cmax).
AUCt is defined 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).
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Nicorette Extra Mint 2 mg Gum |
| Treatment B | ACTIVE_COMPARATOR | Nicorette Mint 2 mg Gum |
| Treatment C | EXPERIMENTAL | Nicorette Extra Mint 4 mg Gum |
| Treatment D | ACTIVE_COMPARATOR | Nicorette Mint 4 mg Gum |
| Name | Type | Description |
|---|---|---|
| Nicorette Extra Mint 2 mg Gum | DRUG | A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes. |
| Nicorette Mint 2 mg Gum | DRUG | A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes. |
| Nicorette Extra Mint 4mg Gum | DRUG | A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes. |
| Nicorette Mint 4 mg Gum | DRUG | A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes. |
Inclusion Criteria: 1. Healthy male subjects between the ages of 18 and 55 years, inclusive, and healthy female subjects between the ages of 18 and 45 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examinati...
Nicorette Mint Gum is a nicotine replacement therapy used for tobacco dependence. It is a small molecule medicine developed by Johnson & Johnson, which trades under the ticker JNJ. The product is also known as Nicorette Mint 2 mg Gum.
Nicorette Mint Gum is used for tobacco dependence, helping people reduce or quit smoking by delivering nicotine to ease withdrawal symptoms and cravings. It belongs to the psychiatry therapeutic area and is a small molecule nicotine replacement product.
Nicorette Mint Gum is made by Johnson & Johnson, the pharmaceutical and consumer health company that trades on the New York Stock Exchange under the ticker JNJ. Johnson & Johnson is the developer behind the Nicorette Mint Gum product.
Nicorette Mint Gum has been studied in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. It is an investigational product in the clinical research setting rather than a newly approved therapy.
Nicorette Mint Gum has been evaluated in one completed Phase 1 trial, NCT03259607, titled a clinical study to assess bioequivalence between Nicorette Extra Mint Gum and Nicorette Mint Gum in healthy smokers. The trial enrolled 76 participants in China and was active controlled and randomized.