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Trial record 7 of 507 for:    MOXIFLOXACIN

The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01876316
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University

Brief Summary:
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Condition or disease Intervention/treatment Phase
Healthy Drug: Moxifloxacin Drug: Placebo Not Applicable

Detailed Description:
The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Moxifloxacin
single oral administration of 400mg of moxifloxacin
Drug: Moxifloxacin
single oral administration of 400mg of moxifloxacin
Other Name: Avelox

Placebo Comparator: Placebo
single oral administration of 400mg of placebo
Drug: Placebo
single oral administration of 400mg of placebo
Other Name: Lactose




Primary Outcome Measures :
  1. double delta QTcF [ Time Frame: up to 24 hours ]
    12 point of ECG measurements according to the interventions


Secondary Outcome Measures :
  1. double delta QTcI, double delta QTcSS [ Time Frame: up to 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.

2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ [height (m)]2.

Exclusion Criteria:

  • 1) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.

    2) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.

  • Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
  • PR ≥ 210 msec
  • QRS ≥ 120 msec
  • QT ≥ 500 msec
  • QTcF: male ≥ 450 msec, female ≥470msec
  • Iincomplete right bundle branch block
  • Marked Sinus Arrhythmia
  • Wondering pacemaker
  • Atrial rhythm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876316


Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Jae-Gook Shin, MD, PhD Inje University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University
ClinicalTrials.gov Identifier: NCT01876316     History of Changes
Other Study ID Numbers: 12-166
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013
Keywords provided by Jae-Gook Shin, Inje University:
Moxifloxacin
QT interval prolongation
Korean
Japanese
Additional relevant MeSH terms:
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Moxifloxacin
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