Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04478357 | BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG | PHASE1 | COMPLETED | 18 | — | — | Nov 12, 2019 | Nov 12, 2020 | May 7, 2021 | 1 | Belgium |
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...