A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
NCT ID: NCT01529957
Last Updated: 2012-02-20
Study Results
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Basic Information
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COMPLETED
PHASE1
176 participants
INTERVENTIONAL
2008-09-30
2011-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Nemonoxacin Malate Sodium Chloride 25 mg
Nemonoxacin Malate Sodium Chloride 25 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 50 mg
Nemonoxacin Malate Sodium Chloride 50 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 125 mg
Nemonoxacin Malate Sodium Chloride 125 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
placebol
placebol
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 250 mg
Nemonoxacin Malate Sodium Chloride 250 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 500 mg
Nemonoxacin Malate Sodium Chloride 500 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 650 mg
Nemonoxacin Malate Sodium Chloride 650 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 750 mg
Nemonoxacin Malate Sodium Chloride 750 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 1000 mg
Nemonoxacin Malate Sodium Chloride 1000 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Nemonoxacin Malate Sodium Chloride 1250 mg
Nemonoxacin Malate Sodium Chloride 1250 mg
Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Interventions
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Nemonoxacin Malate Sodium Chloride
Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
Eligibility Criteria
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Inclusion Criteria
2. A male volunteer should be willing to use a double-barrier contraception until the study is completed, and should not make his partner pregnant during the study and within 3 months after completing the study
3. Volunteers who have never used any tobacco or nicotine-containing product within three months before use of the investigational product
4. Volunteers who are willing to abstain from caffeine- or xanthine- containing drinks or food within 24h before being enrolled in the study and throughout the study,such as coffee and tea,chocolate,alcohol, grapefruit juice,orange juice,etc.
5. The body mass index (BMI) of the volunteer must be 19\~24, and the weight of a male should be at least 50kg,and that of a female should be at least 45kg.
6. Volunteers who are able to sign the informed consent form (ICF) of their own accord.
Exclusion Criteria
2. Had surgery or trauma within 6 months prior to this study
3. Alcohol or drug abuse
4. HIV, HBV or HCV positive
5. subject used any known hepatic enzyme inducer/hepatic enzyme inhibitor product within 30 days prior to the study
6. Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
7. Donated 400ml of blood or plasma within 3 months prior to this study
8. Have an abnormal laboratory examination value that exceeds the normal range by 10%
9. Drug allergies
10. Have cardiac disorders or have a family history of cardiac disorders
11. Have abnormal 12-lead ECG during screening
12. Pregnant or lactating
13. Participated in any study within 3 months prior to this study
14. according to the investigator's judgment, affect the safety or efficacy evaluation.
18 Years
45 Years
ALL
Yes
Sponsors
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TaiGen Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yingyuan Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital, Fundan University
Locations
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Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Zhen Hospital, Capital Medical University Beijing
Beijing, , China
Kunming General Hospital of Chengdu Military Region
Chengdu, , China
West China Hospital of Sichuan University
Chengdu, , China
Second Affiliated Hospital, Third Military Medical University
Chongqing, , China
Third Military Medical University First Affiliated Hospital
Chongqing, , China
Third Military Medical University, Third Affiliated Hospital
Chongqing, , China
Second Affiliated Hospital of Dalian Medical University
Dalian, , China
Gansu Provincial People's Hospital
Gansu, , China
Guangzhou Red Cross Hospital
Guangzhou, , China
Second Affiliated Hospital of Sun Yat-sen
Guangzhou, , China
Hangzhou First People's Hospital
Hangzhou, , China
Third Xiangya Hospital, Central South University
Hunan, , China
Xiangya Hospital, Central South University
Hunan, , China
Jiangxi Provincial People's Hospital
Jiangxi, , China
Second Affiliated Hospital of Nanchang University
Jiangxi, , China
Shengjing Hospital of China Medical University
Liaoning, , China
Huai'an First Hospital of Nanjing Medical University
Nanjing, , China
Affiliated Hospital of Qingdao University Medical College
Qingdao, , China
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, , China
Shanghai Changzheng Hospital
Shanghai, , China
Shanghai Pudong New Area, Oriental Hospital
Shanghai, , China
People's Liberation Army General Hospital of Shenyang Military Region
Shenyang, , China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
First Affiliated Hospital,Zhejiang University School of Medicine
Zhejiang, , China
Countries
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Other Identifiers
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TG-873870-C-2
Identifier Type: -
Identifier Source: org_study_id
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