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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

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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 of Trial: Phase I

Latest Information Update: 12 Feb 2021

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At a glance

  • Drugs Fesoterodine (Primary)
  • Indications Overactive bladder
  • Focus Pharmacokinetics
  • Sponsors Pfizer

    • Most Recent Events

    • 08 Feb 2021 Status changed from recruiting to completed.
    • 11 Aug 2020 Planned End Date changed from 19 Mar 2021 to 18 Mar 2021.
    • 11 Aug 2020 Planned primary completion date changed from 19 Mar 2021 to 18 Mar 2021.

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