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Clinical Study on Oral Nemonoxacin Malate Capsules

Sponsor
TaiGen Biotechnology Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01395108
Collaborator
(none)
76
Enrollment
1
Location
6
Arms
7
Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase I Clinical Study on Oral Nemonoxacin Malate Capsules
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo

Drug: Nemonoxacin
oral once daily
Other Names:
  • TG-873870

    		•
    Active Comparator: Nemonoxacin 125mg

    Nemonoxacin 125mg

    Drug: Nemonoxacin
    oral once daily
    Other Names:
  • TG-873870

    		•
    Active Comparator: Nemonoxacin 250mg

    Nemonoxacin 250mg

    Drug: Nemonoxacin
    oral once daily
    Other Names:
  • TG-873870

    		•
    Active Comparator: Nemonoxacin 500mg

    Nemonoxacin 500mg

    Drug: Nemonoxacin
    oral once daily
    Other Names:
  • TG-873870

    		•
    Active Comparator: Nemonoxacin 750mg

    Nemonoxacin 750mg

    Drug: Nemonoxacin
    oral once daily
    Other Names:
  • TG-873870

    		•
    Active Comparator: Nemonoxacin 1000mg

    Nemonoxacin 1000mg

    Drug: Nemonoxacin
    oral once daily
    Other Names:
  • TG-873870

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers [7 days]

    2. Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers [7 days]

    3. Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers [17 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Antibiotics, Huashan Hospital, Fundan University Shanghai China 200040

    Sponsors and Collaborators

    • TaiGen Biotechnology Co., Ltd.

    Investigators

    • Principal Investigator: Yingyuan Zhang, PhD, Huashan Hospital, Fundan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01395108
    Other Study ID Numbers:
    • TG-873870-C-1
    First Posted:
    Jul 15, 2011
    Last Update Posted:
    Jul 15, 2011
    Last Verified:
    Jul 1, 2011

    Study Results

    No Results Posted as of Jul 15, 2011