NCT04476407

Pharmacokinetics of Benapenem in Subjects With Renal Impairment

"Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-06-15
• Primary completion: 2019-10-21
• Completion: 2019-10-21
• First posted: 2020-07-20
• Last updated: 2020-07-20

Locations

1 site across 1 country: China