"Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Renal clearance (CLr)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.18~75 years old
- •BMI 17 to 30 kg/m2
- •No known diseases or significant abnormalities on physical exam (subjects with normal renal function only)
- •eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only)
- •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)
排除标准
- •Hypersensitivity to any of the beta-lactam antibiotics
- •2.Conditions or disease that may interfere with the evaluation of study drug
- •Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration;
- •Drug abuse in 2 years
- •A blood donation or more than 400 ml of blood loss within 3 months
研究组 & 干预措施
G1
subjects with nomal renal function
干预措施: benapenem (Drug)
G2
subjects with mild renal impairment
干预措施: benapenem (Drug)
G3
subjects with moderate renal impairment
干预措施: benapenem (Drug)
结局指标
主要结局
Renal clearance (CLr)
时间窗: 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
时间窗: 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)
Observed terminal elimination half-life (T1/2)
时间窗: 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
Apparent volume of distribution (Vz)
时间窗: 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
时间窗: 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
Area under the plasma concentration-time curve
时间窗: 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 infinity ( AUC0-inf ) of benapenem and the metabolite
Maximum observed plasma concentration(Cmax)
时间窗: 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
Total body clearance (CLt)
时间窗: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Total body clearance (CLt) of benapenem
次要结局
未报告次要终点