The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
Single dose safety and tolerability study: evaluate safety and tolerability of intravenous infusion nemonoxacin 25mg, 50mg, 125mg, 250mg, 500mg, 750mg, 1000mg and 1250mg. Single dose pharmacokinetic (PK) study:evaluate PK profile of doses of 250mg, 500mg or 750mg intravenous infusion nemonoxacin . Multiple dose study: evaluate PK profile of doses of 500mg, 650mg or 750mg intravenous infusion nemonoxacin after consecutive 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
176
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Peking University First Hospital
Adverse event assessment in healthy Chinese volunteer
Time frame: 46days
Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers
Time frame: 32days
Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers
Time frame: 4days
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Beijing, China
Peking University People's Hospital
Beijing, China
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West China Hospital of Sichuan University
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Second Affiliated Hospital, Third Military Medical University
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Third Military Medical University First Affiliated Hospital
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Third Military Medical University, Third Affiliated Hospital
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Second Affiliated Hospital of Dalian Medical University
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Gansu Provincial People's Hospital
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...and 16 more locations