Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicorette Extra 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 Extra Mint Gum is used for tobacco dependence, specifically to help healthy smokers manage nicotine withdrawal. It is a small molecule product being developed by Johnson & Johnson (JNJ) for the psychiatry therapeutic area. The gum is intended as a nicotine replacement therapy to support smoking cessation efforts.
Nicorette Extra Mint Gum is made by Johnson & Johnson, which trades under the ticker JNJ. The company is developing this small molecule product for tobacco dependence. The product is currently in Phase 1 clinical development, with one completed trial evaluating its bioequivalence to another Nicorette product.
Nicorette Extra Mint Gum is in Phase 1 clinical development. It is an investigational product, not yet approved, and is being studied for tobacco dependence. One Phase 1 trial has been completed, which assessed bioequivalence in healthy smokers. The product remains under clinical investigation by Johnson & Johnson.
Nicorette Extra Mint Gum has one completed clinical trial, NCT03259607, titled 'Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers.' This Phase 1 study enrolled 76 participants in China, was active-controlled, and included biomarker selection. The trial has been completed.
Nicorette Extra Mint Gum is a distinct product being studied for bioequivalence to Nicorette Mint Gum. The completed clinical trial NCT03259607 compared the two formulations in healthy smokers to assess whether they are equivalent. The study was active-controlled and enrolled 76 participants in China.