A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.
研究概览
简要总结
This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects have standard weight( generally not less than 50 kg), and body mass index (BMI) within 19-
- •All physical examinations( including ECG, kidney function, liver function, blood routine, urine routines, etc) are normal.
- •Subjects have no history of significant diseases, allergy or orthostatic hypotension.
- •All subjects sign the informed consent after being informed all possible adverse drug reaction and .are able to complete all examination defined.
排除标准
- •Subjects who cannot communicate with medical staff, and subjects with cerebral insufficiency or psychological problem.
- •Partner of subjects have plan to pregnant.
- •Subject have primary disease in vital organ.
- •Subjects have a history of drug dependence or psychosis in last 2 years.
- •Subjects with severe blood loss or blood donation more than 200 mL in the prior 3 months.
- •Subjects who have participated in another clinical trial within the prior 3 months.
- •Known or suspected to have a history of alcohol or drug abuse.
- •Subjects who have abnormal clinical significance after checking preclinical laboratory data and physical examinations.
- •Known allergy to pharmaceutical ingredient of Ginkgolides Meglumine Injection or allergy sufferers who are allergic to more than two kinds of food or drugs in the past.
- •Subjects who have used any drugs in the prior 2 weeks.
- •Subjects have unexplained infections.
- •The subjects could not complete the study in the opinion of the Principal Investigator due to any reason.
- •Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) , hepatitis B surface antigen (HbsAg), etc.
研究组 & 干预措施
Midazolam and Ginkgolides Meglumine Injection
Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
干预措施: Midazolam (Drug)
Midazolam and Ginkgolides Meglumine Injection
Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
干预措施: Ginkgolides Meglumine Injection (Drug)
Midazolam and placebo
Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
干预措施: Midazolam (Drug)
Midazolam and placebo
Midazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
干预措施: placebo (Drug)
结局指标
主要结局
Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.
时间窗: Day 1 and Day 22
Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.
时间窗: Day 8
Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.
时间窗: Day 1 and Day 22
Pharmacokinetics parameters：T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.
时间窗: Day 19 and Day22
Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.
时间窗: Day 19
次要结局
- Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.(Day 0, Day 1, Day 8-22 and Day 23)