To observe the pharmacokinetic profiles of benapenem and its major metabolites in healthy volunteers after continuous multiple-dose benapenem, providing evidence for phase Ⅱ/Ⅲclinical study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
2000 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 3000 mg group is then performed
sodium chloride
Peking university first hospital
Beijing, Beijing Municipality, China
RECRUITINGAUC(0-t) of Benapenem
AUC(0-t) is the area under the curve from time 0 to t
Time frame: Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Maximum observed plasma concentration (Cmax) of Benapenem
Maximum observed plasma concentration (Cmax) of Benapenem in healthy subjects
Time frame: Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Time to maximum observed plasma concentration (tmax) of Benapenem
Time to maximum observed plasma concentration (tmax) of Benapenem in healthy subjects
Time frame: Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Time to elimination half-life (t1/2) of Benapenem
Time to elimination half-life (t1/2) of Benapenem in healthy subjects
Time frame: Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Number of subjects with clinically significant findings in vital signs
Vitals signs such as systolic and diastolic blood pressure, heart rate, and pulse rate will be measured in a semi-supine position after 5 minutes of rest
Time frame: Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing
Number of subjects with clinically significant findings in laboratory parameters
Hematology and Clinical Chemistry and Urine routine abnormalities will be monitored
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Time frame: Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing
Number of subjects with clinically significant 12-lead ECGs
Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals.
Time frame: Screening, Day1, Day2, Day4, Day5,Day7, Day8, Day10 after Dosing
Number of subjects with adverse events and serious adverse events
All adverse events will be monitored in each group subjects
Time frame: From Screening to Day 10 after dosing