Clinical Trials Logo
  1. Home
  2. Neurogenic Detrusor Overactivity
  3. 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

Neurogenic Detrusor Overactivity Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04452838
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date June 26, 2020
Completion date January 4, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT01981954 - A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO) Phase 3
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Terminated NCT00712322 - A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity Phase 2
Recruiting NCT06059066 - Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction N/A
Completed NCT01091727 - Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity Phase 3
Recruiting NCT05491525 - A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC Phase 2/Phase 3
Completed NCT02138149 - Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury? N/A
Completed NCT04478357 - BIOEQUIVALENCE STUDY IN HEALTHY PARTICIPANTS COMPARING 4 MG AND 8 MG FESOTERODINE EXTENDED-RELEASE TABLETS (TOVIAZ™), MANUFACTURED AT ZWICKAU VERSUS FREIBURG Phase 1
Completed NCT00857896 - Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years Phase 2
Completed NCT00800462 - Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity Phase 4
Completed NCT01539707 - Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder Phase 1
Completed NCT03482037 - Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury Phase 1/Phase 2
Completed NCT02751931 - Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity Phase 3
Active, not recruiting NCT05502614 - Dorsal Genital Nerve Stimulation for Bladder Management After SCI N/A
Recruiting NCT05621616 - A Study of Mirabegron in Young Children With Neurogenic Detrusor Overactivity Phase 3
Withdrawn NCT01043848 - Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients N/A
Completed NCT02526979 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB) Phase 1
Completed NCT01565694 - A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity Phase 3
Completed NCT03168828 - Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury Phase 1