Clinical Study on Oral Nemonoxacin Malate Capsules
Phase I Clinical Study on Oral Nemonoxacin Malate Capsules
1 other identifier
interventional
76
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jan 2008
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 2011
CompletedJuly 15, 2011
July 1, 2011
7 months
July 13, 2011
July 13, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo
Nemonoxacin 125mg
ACTIVE COMPARATORNemonoxacin 125mg
Nemonoxacin 250mg
ACTIVE COMPARATORNemonoxacin 250mg
Nemonoxacin 500mg
ACTIVE COMPARATORNemonoxacin 500mg
Nemonoxacin 750mg
ACTIVE COMPARATORNemonoxacin 750mg
Nemonoxacin 1000mg
ACTIVE COMPARATORNemonoxacin 1000mg
Interventions
oral once daily
Eligibility Criteria
You may qualify if:
- Healthy males and females, aged between 18 and 45 during screening
- Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study
- No use of tobacco or nicotine product within 3 months prior to this study
- BMI 19-25
- Willing to abstain from coffee and any caffeine drink during the study
- Voluntarily sign the informed consent
You may not qualify if:
- History of diabetes, or cardiovascular, hepatic or renal disease
- Active digestive disease (e.g. diarrhea)
- Central nervous disease or psychiatric disorders
- Had surgery or trauma within 6 months prior to this study
- Alcohol or drug abuse
- HIV, HBV or HCV positive
- Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
- Donated 400ml of blood or plasma within 3 months prior to this study
- Have an abnormal laboratory examination value that exceeds the normal range by 10%
- Drug allergies
- Have cardiac disorders or have a family history of cardiac disorders
- Have abnormal 12-lead ECG during screening
- Pregnant or lactating
- Participated in any study within 3 months prior to this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Antibiotics, Huashan Hospital, Fundan University
Shanghai, 200040, China
Related Publications (1)
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.
PMID: 22650326DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Yingyuan Zhang, PhD
Huashan Hospital, Fundan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2011
First Posted
July 15, 2011
Study Start
January 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 15, 2011
Record last verified: 2011-07