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Clinical Study on Oral Nemonoxacin Malate Capsules

This study has been completed.
Sponsor:
Information provided by:
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01395108
First received: July 13, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
 Drug: Nemonoxacin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Clinical Study on Oral Nemonoxacin Malate Capsules

Resource links provided by NLM:

Drug Information available for: Malic acid
U.S. FDA Resources

Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Nemonoxacin
oral once daily
Other Name: TG-873870
Active Comparator: Nemonoxacin 125mg
Nemonoxacin 125mg
 Drug: Nemonoxacin
oral once daily
Other Name: TG-873870
Active Comparator: Nemonoxacin 250mg
Nemonoxacin 250mg
 Drug: Nemonoxacin
oral once daily
Other Name: TG-873870
Active Comparator: Nemonoxacin 500mg
Nemonoxacin 500mg
 Drug: Nemonoxacin
oral once daily
Other Name: TG-873870
Active Comparator: Nemonoxacin 750mg
Nemonoxacin 750mg
 Drug: Nemonoxacin
oral once daily
Other Name: TG-873870
Active Comparator: Nemonoxacin 1000mg
Nemonoxacin 1000mg
 Drug: Nemonoxacin
oral once daily
Other Name: TG-873870

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395108

Locations
China
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
  More Information

No publications provided by TaiGen Biotechnology Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yingyuan Zhang, Institute of Antibiotics, Huashan Hospital, Fundan University
ClinicalTrials.gov Identifier: NCT01395108     History of Changes
Other Study ID Numbers: TG-873870-C-1
Study First Received: July 13, 2011
Last Updated: July 13, 2011
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013