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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04452838 | Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer | PHASE1 | COMPLETED | 37 | — | — | Jun 26, 2020 | Jan 4, 2021 | Feb 10, 2021 | 1 | Belgium |
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.
Maximum Observed Plasma Concentration
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Sequence 1 (Part A) | OTHER | Treatment Sequence A,B,C and D |
| Cohort 1 Sequence 2 (Part A) | OTHER | Treatment Sequence B, A,C and D |
| Cohort 2 Sequence 1 (Part B) | OTHER | Treatment Sequence E, F, G, and H |
| Cohort 2 Sequence 2 (Part B) | OTHER | Treatment Sequence E, F, H and G |
| Cohort 2 Sequence 3 (Part B) | OTHER | Treatment Sequence F, E, G, and H |
| Cohort 2 Sequence 4 (Part B) | OTHER | Treatment sequence F, E, H, and G |
| Name | Type | Description |
|---|---|---|
| Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B) | DRUG | 4 mg administered under fasted condition. |
| Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B) | DRUG | 4 mg administered under fasted conditions. |
| Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B) | DRUG | 4 mg administered under fed conditions. |
| Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A) | DRUG | 4 mg sprinkled on apple sauce administered under fasting conditions |
| Fesoterodine BIC SR4 fed (Treatment E in Part B) | DRUG | 4 mg administered under fed conditions |
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 medical history, physical examination, and l...