clinical trial · NCT04486625
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Pfizer·phase1·completed·n = 11
Renal InsufficiencyAztreonam-AvibactamAztreonam-Avibactam
brief summary
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modelling/simulation.
started
Aug 10, 2020
primary completion
Sep 20, 2021
completion
Oct 18, 2021
last updated
Jul 28, 2023
official title
AN OPEN-LABEL, PARALLEL-GROUP, PHARMACOKINETIC STUDY OF MULTIPLE INTRAVENOUS DOSES OF AZTREONAM AND AVIBACTAM IN SUBJECTS WITH SEVERE RENAL IMPAIRMENT AND NORMAL RENAL FUNCTION
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol