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Clinical trial

A Phase 1, Single-dose, Open-label, Randomized, 4-way Crossover Zoliflodacin Bioequivalence Study of the Reference Product (ZoliPa) With the Test Product (ZoliDr) in Healthy Adult Volunteers Under Fasted and Specific Fed Conditions Paired With an Investigation of the Effect of Cytochrome P450 3A4 Inhibition by Itraconazole on 3g Zoliflodacin (ZoliPa) Single-dose Pharmacokinetics

NCT05635305 is registered in ClinicalTrials.gov with Global Antibiotics Research and Development Partnership as lead sponsor.

NCT NCT05635305
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1, Single-dose, Open-label, Randomized, 4-way Crossover Zoliflodacin Bioequivalence Study of the Reference Product (ZoliPa) With the Test Product (ZoliDr) in Healthy Adult Volunteers Under Fasted and Specific Fed Conditions Paired With an Investigation of the Effect of Cytochrome P450 3A4 Inhibition by Itraconazole on 3g Zoliflodacin (ZoliPa) Single-dose Pharmacokinetics
Lead sponsor
Global Antibiotics Research and Development Partnership
Phase
Phase 1
Overall status
Completed
Start date
November 9, 2022
Completion date
February 7, 2023
Enrollment
50 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteers