A Phase 1 interventional study of ziprasidone and B16 Fasted in Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Basic science
Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Commercial Geodon (ziprasidone) capsules given with food
Drug: ziprasidone
Experimental reduced food effect formulation given without food
Drug: B16 Fasted
Experimental reduced food effect formulation given with food
Drug: B16 Fed
40 mg capsule, single dose x 3
Also known as: Geodon, Zeldox
40 mg tablet, single dose X 3
40 mg tablet, single dose X 3
Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments.
Time frame: 2 months
Adverse events reported, laboratory test results, vital signs observed with each study treatment
Time frame: 2 months
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.