scholarly journals An open‐label study to estimate the effect of steady‐state erythromycin on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban in subjects with renal impairment and normal renal function

2014 ◽  
Vol 54 (12) ◽  
pp. 1407-1420 ◽  
Author(s):  
Kenneth T. Moore ◽  
Seema Vaidyanathan ◽  
Jaya Natarajan ◽  
Jay Ariyawansa ◽  
Lloyd Haskell ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Steady State ◽  
Renal Impairment ◽  
Normal Renal Function ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function

2018 ◽  
Vol 62 (12) ◽  
Author(s):  
Allison S. Komirenko ◽  
Valerie Riddle ◽  
Jacqueline A. Gibbons ◽  
Scott Van Wart ◽  
Julie D. Seroogy
Keyword(s):  
Renal Function ◽  
Renal Impairment ◽  
Normal Renal Function ◽  
Severe Renal Impairment ◽  
Phase 1 ◽  
Open Label ◽  
Time Curve ◽  
Open Label Study ◽  
Severe Impairment ◽  
Tract Infections

ABSTRACTPlazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infections. In this open-label study, 24 adults with normal renal function or mild, moderate, or severe renal impairment (n= 6 per group) received a single 7.5-mg/kg of body weight dose of plazomicin as a 30-min intravenous infusion. Total clearance declined with renal impairment, resulting in 1.98-fold and 4.42-fold higher plazomicin exposures, as measured by the area under the concentration-time curve from 0 h to infinity, in subjects with moderate and severe impairment, respectively, than in subjects with normal renal function. (This study has been registered at ClinicalTrials.gov under identifier NCT01462136.)

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