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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China
Pharmacokinetics parameters:Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.
Time frame: Day 1 and Day 22
Pharmacokinetics parameters:AUC0-24h(Day 22/ Day 1)、Cmax(Day 22/ Day 1)for Midazolam.
Time frame: Day 1 and Day 22
Pharmacokinetics parameters:Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.
Time frame: Day 8
Pharmacokinetics parameters:T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.
Time frame: Day 19 and Day22
Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.
Time frame: Day 19
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.
Adverse event reports will be assessed at Day1, Day 8-22, Day 23. Vital sign measurements will be assessed at Screening stage, Day 0, Day 1, Day 8-22, Day 23. Electrocardiogram monitoring will be assessed at Day 1, Day 8-22. Clinical laboratory tests will be assessed at Screening stage and Day 23. Electrocardiogram will be assessed at Screening stage, Day 0, Day 8-22 and Day 23
Time frame: Day 0, Day 1, Day 8-22 and Day 23
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