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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 26, 2020

Primary Completion Date

January 4, 2021

Study Completion Date

January 4, 2021

Conditions

Neurogenic Detrusor Overactivity

Interventions

DRUG

Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)

4 mg administered under fasted condition.

DRUG

Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)

4 mg administered under fasted conditions.

DRUG

Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)

4 mg administered under fed conditions.

DRUG

Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)

4 mg sprinkled on apple sauce administered under fasting conditions

DRUG

Fesoterodine BIC SR4 fed (Treatment E in Part B)

4 mg administered under fed conditions

Trial Locations (1)

Brussels Clinical Research Unit, Brussels