Status:
COMPLETED
Pharmacokinetics of Benapenem in Subjects With Renal Impairment
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Conditions:
Complicated Urinary Tract Infection; Cuti
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 heal...
Eligibility Criteria
Inclusion
- 18\~75 years old
- 2\. BMI 17 to 30 kg/m2
- 3\. No known diseases or significant abnormalities on physical exam (subjects with normal renal function only)
- 4\. eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only)
- 5\. eGFR 30 to 59 mL/min/1.73m2 (subjects with mild renal impairment only); eGFR 60 to 89 mL/min/1.73m2 (subjects with moderate renal impairment only)
Exclusion
- 1\. Hypersensitivity to any of the beta-lactam antibiotics
- Conditions or disease that may interfere with the evaluation of study drug
- 3\. Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration;
- 4\. Drug abuse in 2 years
- 5\. A blood donation or more than 400 ml of blood loss within 3 months
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04476407
Start Date
June 15 2019
End Date
October 21 2019
Last Update
July 20 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China, 200092