Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fesoterodine BIC SR4 fed · 1 trial · 1 indication
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...
Fesoterodine BIC SR4 fed is an investigational small molecule being developed for neurogenic detrusor overactivity, a urologic condition characterized by involuntary bladder contractions. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Fesoterodine BIC SR4 fed is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical trials to evaluate the drug's pharmacokinetic properties in healthy volunteers.
Fesoterodine BIC SR4 fed is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet received marketing approval from regulatory agencies.
Fesoterodine BIC SR4 fed was studied in a completed Phase 1 trial with the identifier NCT04452838. This trial enrolled 37 participants in Belgium and assessed bioequivalence of different formulations under fed and fasted conditions, as well as bioavailability of a sprinkled formulation.
Fesoterodine BIC SR4 fed is a specific formulation of fesoterodine, a medication used for overactive bladder. The BIC SR4 designation refers to a beads-in-capsule sustained release formulation, and the fed component indicates the trial evaluated administration with food.