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Moxifloxacin_QT Study in Chinese Healthy Volunteer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Haiyan Li, Peking University Third Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Haiyan Li, Peking University Third Hospital Identifier:
First received: July 27, 2012
Last updated: July 30, 2012
Last verified: July 2012
A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in healthy Chinese subjects.

Condition Intervention
QT Interval Prolongation Drug: moxifloxacin Drug: moxifloxacin-placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Double-blinded, 2-way Crossover, Placebo-controlled Study to Assess the QT/QTc Interval After Administration of Single Oral Dose of 400mg Moxifloxacin in Healthy Chinese Subjects

Resource links provided by NLM:

Further study details as provided by Haiyan Li, Peking University Third Hospital:

Primary Outcome Measures:
  • baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF) [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Heart rate, PR, QRS, QTcB and QTcI [ Time Frame: 1 month ]

Estimated Enrollment: 36
Study Start Date: July 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: moxifloxacin, pill
Oral dose of 400mg moxifloxacin
Drug: moxifloxacin
oral dose of 400mg moxifloxacin
Drug: moxifloxacin-placebo
Oral dose of a pill of moxifloxacin-placebo
Placebo Comparator: moxifloxacin-placebo,pill
A pill of moxifloxacin-placebo
Drug: moxifloxacin
oral dose of 400mg moxifloxacin
Drug: moxifloxacin-placebo
Oral dose of a pill of moxifloxacin-placebo


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy Chinese subjects, male, 20 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
  2. At Screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for 5 minutes. All of vital signs should be within normal ranges:

    • Body temperature (Body) between 35.0-37.0°C
    • 90 ≤ systolic blood pressure <140 mm Hg
    • 60≤ diastolic blood pressure < 90 mm Hg
    • 50≤ pulse rate ≤ 100
  3. Body weight need to be at least 50kg or above, 19kg/m2≤ Body Mass Index(BMI) ≤25kg/m2
  4. Be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent prior to any screening procedures.

Exclusion Criteria:

  1. History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, genetic or psychiatric disorders.
  2. A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of long QT syndrome, or QTc interval > 440 ms for male or any abnormal ECG findings at screening.
  3. Medical histories of syncope, electrophysiological changes, heart failure, reduced exercise tolerance, cardiomyopathy, pericarditis, myocarditis or other cardiac disorders as determined by the investigator.
  4. Current electrolyte abnormalities (specifically hypokalemia) in laboratory examination during the screening that are clinical significant as determined by investigator.
  5. Current or recent history (< 30 days prior to Screening) of a clinically significant illness.
  6. Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 4 week prior to initial dosing.
  7. Positive results of human immunodeficiency virus, Hepatitis B surface antigen or Hepatitis C antibody testing.
  8. History of any hypersensitivity or allergic reaction of moxifloxacin or other types fluoroquinolones.
  9. Use of tobacco or history of use of tobacco ( > 5 tobacco/week) or nicotine-containing products in the 3 months prior to screening.
  10. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and/or at baseline.
  11. Dosing of study drug in any clinical investigation within 3 months prior to initial dosing.
  12. Donation or loss of 200 ml or more of blood within 3 months prior to participation, or donation of component blood within 3 months prior to participation.
  13. Consumption of alcohol-, caffeine --containing foods or beverages within 48 hours preceding study drug administration.
  14. Other conditions which investigator deems potential harm to subjects if participate the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01653990

Contact: Jingchuan Guo, MD 861082265509
Contact: Haiyan Li, MD 861082266226

Peking University Third Hospital Drug Clinical Trial Center Recruiting
Beijing, China, 100191
Contact: Haiyan Li, MD    861082266226   
Sub-Investigator: Jingchuan Guo, MD         
Sponsors and Collaborators
Peking University Third Hospital
Principal Investigator: Haiyan Li, MD Peking University Third Hospital
  More Information

Responsible Party: Haiyan Li, Director of Drug Clinical Trial Center, Peking University Third Hospital Identifier: NCT01653990     History of Changes
Other Study ID Numbers: DCTC_2012001
Study First Received: July 27, 2012
Last Updated: July 30, 2012

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors processed this record on August 18, 2017