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...