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

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, CROSSOVER STUDY TO ASSESS THE BIOEQUIVALENCE UNDER FED AND FASTED CONDITIONS OF FESOTERODINE BEADS-IN-CAPSULE SR7 AND SR4 FORMULATIONS, THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF THE BEADS-IN-CAPSULE SR7 FORMULATION AND TO ESTIMATE THE BIOAVAILABILITY OF SR7 BEADS SPRINKLED ON APPLE SAUCE RELATIVE TO THE BEADS-IN-CAPSULE SR7 FORMULATION ADMINISTERED INTACT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Open Label, Single-Dose, Crossover Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule (BIC) SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administered Intact.

Detailed description

After oral administration, fesoterodine is not detected in plasma as it is rapidly and extensively hydrolyzed by non-specific esterases to its primary active metabolite 5-hydroxymethyl tolterodine (5-HMT) . Therefore characterization of the rate and extent of absorption of the test and reference fesoterodine formulations will be based on pharmacokinetic parameters of 5-HMT derived from the 5-HMT concentration-time profiles.

Conditions

• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-01-04
• Completion: 2021-01-04
• First posted: 2020-07-01
• Last updated: 2021-02-10

Locations

1 site across 1 country: Belgium