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nicotine lozenge · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 2 mg nicotine prototype | EXPERIMENTAL | 2 mg nicotine prototype |
| 2 mg nicotine lozenge | ACTIVE_COMPARATOR | marketed formulation |
| 4 mg nicotine prototype | EXPERIMENTAL | 4 mg |
| 4 mg nicotine lozenge | ACTIVE_COMPARATOR | 4 mg |
| Name | Type | Description |
|---|---|---|
| 4 mg nicotine lozenge | DRUG | marketed formulation |
| 2 mg nicotine lozenge | DRUG | marketed formulation |
| 2 mg nicotine prototype | DRUG | 2 mg |
| 4 mg nicotine prototype | DRUG | 4 mg |
Inclusion Criteria: * Subject is either male or female between 18 - 55 years of age inclusive. * Subject has a BMI within the range 19-27 kg/m². \[BMI = Weight (kg) ÷ Height (m)²\]. * Subject admits to having smoked commercially-available cigarettes daily for the preceding 12 months and to routinel...
Nicotine lozenge is a small-molecule nicotine replacement product developed by GSK plc under the ticker GSK. It is designed to deliver nicotine through a lozenge formulation. GSK has studied it in a Phase 1 bioequivalence trial in healthy adult smokers, comparing two formulations of the lozenge.
Nicotine lozenge targets the nicotinic acetylcholine receptor subunits CHRNB2 and CHRNA4. It acts as an agonist at these receptors, meaning it binds and activates them. This receptor activity is the basis for its use as a nicotine replacement approach in smokers.
Nicotine lozenge is made by GSK plc, which trades under the ticker GSK. GSK is the developer associated with the lozenge formulation studied in the Phase 1 bioequivalence trial NCT00651352.
Nicotine lozenge is in Phase 1 development. The only listed trial is a completed Phase 1 bioequivalence study, NCT00651352, which enrolled 32 healthy adult smokers. There are no active trials recorded for this asset.
Nicotine lozenge has been studied in one clinical trial, NCT00651352, titled A Single Dose Bioequivalence Study Of Two Formulations Of Nicotine Lozenges. It was a completed Phase 1 trial with 32 randomized participants, an active-controlled design, and enrollment of healthy volunteer smokers aged 18 years and older.