Open-label, Two-period, One Sequence, Multiple Dose, Crossover Study, A Study to Investigate Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment
研究概览
简要总结
- This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid & ertapenem combination treatment
- This trial is performed to evaluate safety of the combination treatment compare with single treatment
- The investigators carry this trial out to study mechanism of combination treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who are healthy volunteers, men 19~50 years
- •Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight
排除标准
- •Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease
- •Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- •Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
- •Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)
- •Subjects with a history of drug abuse
- •Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week
- •Subjects who participated in other clinical investigation within 2months prior to first administration Subjects who did whole blood donation (within 2months) or apheresis (within 1months) prior to first administration
- •Subjects who are chronic drinkers
研究组 & 干预措施
Valproic acid
干预措施: Valproic acid and Ertapenem (Drug)
结局指标
主要结局
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment
时间窗: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment
时间窗: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid single treatment
时间窗: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment
时间窗: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
次要结局
未报告次要终点