The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
192
oral form,,once adily,7\~10 days
oral form,,once adily,7\~10 days
oral form,once daily,7\~10 days
Per subject clinical cure rate
Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable.
Time frame: 16days
Per subject microbiological cure rate
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
Time frame: 16days
Pharmacokinetic profile of nemonoxacin in CAP subjects
Time frame: 3days
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...and 22 more locations