Overview

Pharmacokinetics of Benapenem in Subjects With Renal Impairment

Status:
Completed
Trial end date:
2019-10-21
Target enrollment:
Participant gender:
Summary
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)
Phase:
Phase 1
Details
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.