MedTrace Logo

Pharmacokinetics of Benapenem in Subjects With Renal Impairment

NCT04476407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-07-20

No results posted yet for this study

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)

Conditions

  • Complicated Urinary Tract Infection; Cuti

Interventions

DRUG

benapenem

single-dose Benapenem 1.0mg(iv), 60min infusion

DRUG

benapenem

single-dose Benapenem 1.0mg(iv), 60min infusion

DRUG

benapenem

single-dose Benapenem 1.0mg(iv), 60min infusion

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2019-10-21
Completion
2019-10-21

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476407 on ClinicalTrials.gov