Complicated Urinary Tract Infection; Cuti
Conditions
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 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)
Interventions
DRUGbenapenem
single-dose Benapenem 1.0mg(iv), 60min infusion
Sponsors
Sihuan Pharmaceutical Holdings Group Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 1.18\ 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 criteria
* 1\. Hypersensitivity to any of the beta-lactam antibiotics * 2.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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose | Area under the plasma concentration-time curve from time 0 to the time of thelast quantifiable concentration (AUC0-t )of benapenem and the metabolite |
| Maximum observed plasma concentration(Cmax) | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose | Maximum observed plasma concentration(Cmax) of benapenem and the metabolite |
| Observed terminal elimination half-life (T1/2) | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | Observed terminal elimination half-life (T1/2) of benapenem and its metabolite |
| Total body clearance (CLt) | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | Total body clearance (CLt) of benapenem |
| Apparent volume of distribution (Vz) | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | Apparent volume of distribution (Vz) based on the terminal phase of benapenem |
| Cumulative urine exeretion | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | Cumulative urine exeretion (Ae0-72h%) of benapenem and its metabolite |
| Renal clearance (CLr) | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | Renal clearance (CLr) of Benapenem and its metabolite |
| Metabolite-to-parent ratio of AUC0-inf | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | Metabolite-to-parent ratio of AUC0-inf (MR) |
Countries
China
Outcome results
None listed