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Fesoterodine from Zwickau · 1 trial · 1 indication
Maximum Observed Plasma Concentration (Cmax) of 5-Hydroxymethyl-tolterodine (5-HMT)
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0 - ∞)\] of 5-Hydroxymethyl-tolterodine (5-HMT)
| Arm | Type | Description |
|---|---|---|
| Treatment A | OTHER | 4 mg fesoterodine ER tablet manufactured at Zwickau. |
| Treatment B | OTHER | 4 mg fesoterodine ER tablet manufactured at Freiburg |
| Treatment C | OTHER | 8 mg fesoterodine ER tablet manufactured at Zwickau |
| Treatment D | OTHER | 8 mg fesoterodine ER tablet manufactured at Freiburg. |
| Name | Type | Description |
|---|---|---|
| 4 mg Fesoterodine ER tablet from Zwickau | DRUG | Manufactured at Zwickau |
| 4 mg fesoterodine ER tablet from Freiburg | DRUG | Manufactured at Freiburg |
| 8 mg fesoterodine ER tablet from Zwickau | DRUG | Manufactured at Zwickau |
| 8 mg fesoterodine ER tablet from Freiburg | DRUG | Manufactured at Freiburg |
Inclusion Criteria: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD). 2. Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physic...
Fesoterodine from Zwickau is a 4 mg extended-release fesoterodine tablet manufactured at Pfizer's Zwickau site. It is a small molecule developed by Pfizer, Inc. (PFE) and studied in neurogenic detrusor overactivity, a urology condition. The Zwickau formulation was evaluated in a Phase 1 bioequivalence study against the Freiburg-manufactured tablet.
Fesoterodine from Zwickau is being studied for neurogenic detrusor overactivity, a urology condition in which involuntary bladder contractions occur. The 4 mg extended-release tablet was tested in healthy participants as part of a bioequivalence study, not in patients with the condition. It remains an investigational formulation in clinical development.
Fesoterodine from Zwickau targets CHRM2 and CHRM3, the muscarinic acetylcholine receptor subtypes M2 and M3. It acts as an antagonist at these receptors. By blocking muscarinic signaling in the bladder, the drug is designed to reduce detrusor muscle contractions, which is the rationale for studying it in neurogenic detrusor overactivity.
Pfizer, Inc. (ticker PFE) develops and manufactures Fesoterodine from Zwickau. The tablet is produced at Pfizer's Zwickau manufacturing site, and the Phase 1 bioequivalence study compared product made at Zwickau with product made at Freiburg. Pfizer is the sponsor of the registered clinical trial for this formulation.
Fesoterodine from Zwickau is in Phase 1 development. The single registered trial, NCT04478357, is a completed Phase 1 bioequivalence study in healthy participants. It is an investigational formulation and is not described as approved for any indication.
Fesoterodine from Zwickau has been studied in one clinical trial, NCT04478357, titled a bioequivalence study in healthy participants comparing 4 mg and 8 mg fesoterodine extended-release tablets (Toviaz) manufactured at Zwickau versus Freiburg. The Phase 1 trial enrolled 18 participants in Belgium, was randomized and controlled, and is now completed.