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The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg.
Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Nemonoxacin 125mg | Active Comparator | Nemonoxacin 125mg |
|
| Nemonoxacin 250mg | Active Comparator | Nemonoxacin 250mg |
|
| Nemonoxacin 500mg | Active Comparator | Nemonoxacin 500mg |
|
| Nemonoxacin 750mg | Active Comparator | Nemonoxacin 750mg |
|
| Nemonoxacin 1000mg | Active Comparator | Nemonoxacin 1000mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemonoxacin | Drug | oral once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers | 7 days | |
| Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers | 7 days | |
| Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers | 17 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingyuan Zhang, PhD | Huashan Hospital, Fundan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Antibiotics, Huashan Hospital, Fundan University | Shanghai | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22650326 | Derived | Guo B, Wu X, Zhang Y, Shi Y, Yu J, Cao G, Zhang J. Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses. Clin Drug Investig. 2012 Jul 1;32(7):475-86. doi: 10.2165/11632780-000000000-00000. |
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| ID | Term |
|---|---|
| C543520 | nemonoxacin |
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