Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being studied for neurogenic detrusor overactivity, a condition of involuntary bladder contractions due to nerve damage. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
Fesoterodine from Zwickau is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 1 clinical trials for neurogenic detrusor overactivity.
Fesoterodine from Zwickau is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.
Fesoterodine from Zwickau has one completed clinical trial, NCT04478357, a Phase 1 bioequivalence study in healthy participants comparing 4 mg and 8 mg extended-release tablets manufactured at Zwickau versus Freiburg. The trial enrolled 18 participants in Belgium.
Fesoterodine from Zwickau is a formulation of fesoterodine, the active ingredient in Toviaz. The clinical trial NCT04478357 specifically compares tablets manufactured at Zwickau versus Freiburg to assess bioequivalence.