A Phase 1 interventional study of PA21 and Digoxin in Drug Interaction Potentiation, sponsored by Vifor Pharma. Completed at 1 site in United States. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-18.
Sponsored by Vifor Pharma · Phase 1, Interventional, and Basic science
The purpose of this study is to determine if Digoxin is affected by PA21.
Vifor Pharma is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day
Drug: PA21 · Drug: Digoxin
The maximum dosage of Digoxin will be 0.5 mg/day
Drug: Digoxin
The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day
Drug: PA21 · Drug: Digoxin
The maximum dose of PA21 will be 15.0 g/day.
The maximum dosage of Digoxin will be 0.5 mg/day
Area Under the Curve from time zero to 24 hours (AUC0-24)
Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22
Area Under the Curve from time zero to infinite (AUC0-infinity)
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22
Maximum observed plasma concentration (Cmax)
Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on days 0, 11, 22
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Vifor Pharma