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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

NCT04452838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-02-10

No results posted yet for this study

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.

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-01-04
Completion
2021-01-04

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452838 on ClinicalTrials.gov