Complicated Urinary Tract Infection; Cuti Clinical Trial
Official title:
"Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "
| Verified date | April 2019 |
| Source | Sihuan Pharmaceutical Holdings Group Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | October 21, 2019 |
| Est. primary completion date | October 21, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Tongji Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Sihuan Pharmaceutical Holdings Group Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under the plasma concentration-time curve | Area under the plasma concentration-time curve from time 0 to the time of thelast quantifiable concentration (AUC0-t )of benapenem and the metabolite | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose | |
| Primary | Area under the plasma concentration-time curve | Area under the plasma concentration-time curve from time 0 to infinity ( AUC0-inf ) of benapenem and the metabolite | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose | |
| Primary | Maximum observed plasma concentration(Cmax) | Maximum observed plasma concentration(Cmax) of benapenem and the metabolite | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose | |
| Primary | Observed terminal elimination half-life (T1/2) | Observed terminal elimination half-life (T1/2) of benapenem and its metabolite | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | |
| Primary | Total body clearance (CLt) | Total body clearance (CLt) of benapenem | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | |
| Primary | Apparent volume of distribution (Vz) | Apparent volume of distribution (Vz) based on the terminal phase of benapenem | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | |
| Primary | Cumulative urine exeretion | Cumulative urine exeretion (Ae0-72h%) of benapenem and its metabolite | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | |
| Primary | Renal clearance (CLr) | Renal clearance (CLr) of Benapenem and its metabolite | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose | |
| Primary | Metabolite-to-parent ratio of AUC0-inf | Metabolite-to-parent ratio of AUC0-inf (MR) | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |