A Phase 1 interventional study of Fesoterodine and Fesoterodine in Treatment of Overactive Bladder, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-28.
Sponsored by Pfizer · Phase 1, Interventional, and Other
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 36 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau
Drug: Fesoterodine
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)
Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Also known as: Toviaz 8 mg
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Also known as: Toviaz 8 mg
AUCinf, AUClast, and Cmax of 5-HMT
Time frame: 6 weeks
Tmax and half-life of 5-HMT as data permit.
Time frame: 6 weeks
Safety laboratory tests and adverse events
Time frame: 6 weeks
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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