Clinical Study on Oral Nemonoxacin Malate Capsules

July 13, 2011 updated by: TaiGen Biotechnology Co., Ltd.

Phase I Clinical Study on Oral Nemonoxacin Malate Capsules

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Institute of Antibiotics, Huashan Hospital, Fundan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870
Active Comparator: Nemonoxacin 125mg
Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870
Active Comparator: Nemonoxacin 250mg
Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870
Active Comparator: Nemonoxacin 500mg
Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870
Active Comparator: Nemonoxacin 750mg
Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870
Active Comparator: Nemonoxacin 1000mg
Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers
Time Frame: 7 days
7 days
Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers
Time Frame: 7 days
7 days
Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers
Time Frame: 17 days
17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TaiGen Biotechnology Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • TG-873870-C-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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