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Completed

NCT Number: NCT01529957

A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University First Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female, aged 18 ~45
  • 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
  • Volunteers who have never used any tobacco or nicotine-containing product within three months before use of the investigational product
  • 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.
  • 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.
  • Volunteers who are able to sign the informed consent form (ICF) of their own accord.

Exclusion criteria

  • History of diabetes,or cardiovascular,hepatic or renal disease.
  • Had surgery or trauma within 6 months prior to this study
  • Alcohol or drug abuse
  • HIV, HBV or HCV positive
  • subject used any known hepatic enzyme inducer/hepatic enzyme inhibitor product within 30 days prior to the study
  • 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
  • according to the investigator's judgment, affect the safety or efficacy evaluation.

Treatment and study plan

Nemonoxacin Malate Sodium Chloride

Drug

Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily

Primary outcomes

  1. Adverse event assessment in healthy Chinese volunteer

    Time frame: 46days

  2. Maximum tolerated single dose of nemonoxacin in healthy Chinese volunteers

    Time frame: 32days

Secondary outcomes

  1. Pharmacokinetic profile of nemonoxacin in healthy Chinese volunteers

    Time frame: 4days

Sponsors and collaborators

Lead sponsor

TaiGen Biotechnology Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2012
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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