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CompletedNCT02212795BacteriocideUpdated Jun 29, 2015

Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin

A Phase 1 interventional study of Zabofloxacin 183mg and Levofloxacin 250mg in Healthy, sponsored by Dong Wha Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-29.

Sponsored by Dong Wha Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

Read the detailed description

A Randomized, open label, single dose, crossover phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

02

Conditions studied

  • Healthy

Keywords

  • healthy
03

In context

Lead sponsor

Dong Wha Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A healthy adult within the range of 19 to 65 years old at the time of screening
  • Body Mass Index(BMI)=17.5\~30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2)
  • Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings
  • Doctor checks conducted hematology, blood chemistry, urinalysis and laboratory tests, including an electrocardiogram(EKG) performed during screening tests such as a suitable test subjects who judged
  • The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the Institutional Review Board(IRB)-approved consent form signed by the parties in writing

Exclusion criteria

Exclusion Criteria:

  • One with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence
  • One with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history
  • Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 times the upper limit of the normal range
  • Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g)
  • Take part in other clinical trials within two months
  • Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg
  • The great history of alcohol or drug abuse within 1 year
  • Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
  • More than 20 cigarettes a day smoker
  • Taking medication of a prescription drug or nonprescription within 10 days,
  • Within two months the whole blood donation have, within one month of the apheresis donation have
  • Participate in clinical trials to test drug administration and may be at increased risk due to interpretation of test results, or may interfere with severe supply / chronic medical or mental condition or abnormal laboratory test values in character
  • Pregnant women and lactating mothers
  • Described lifestyle in this protocol can comply with or can not
  • One with other investigator judge to unsuitable
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    A Group

    1st oral administration of Zabofloxacin 183mg, 2nd oral administration of Zabofloxacin 367mg and 3rd oral administration of Levofloxacin 250mg

    Drug: Zabofloxacin 183mg · Drug: Levofloxacin 250mg · Drug: Zabofloxacin 367mg

  • Experimental
    B Group

    1st oral administration of Zabofloxacin 367mg, 2nd oral administration of Levofloxacin 250mg and 3rd oral administration of Zabofloxacin 367mg

    Drug: Zabofloxacin 183mg · Drug: Levofloxacin 250mg · Drug: Zabofloxacin 367mg

  • Experimental
    C Group

    1st oral administration of Levofloxacin 250mg, 2nd oral administration of Zabofloxacin 183mg and 3rd oral administration of Zabofloxacin 367mg

    Drug: Zabofloxacin 183mg · Drug: Levofloxacin 250mg · Drug: Zabofloxacin 367mg

Interventions

  • DrugZabofloxacin 183mg

    Zabofloxacin 183mg single dose

    Also known as: Zabolante 183mg

  • DrugLevofloxacin 250mg

    Levofloxacin 250mg single dose

    Also known as: Cravit

  • DrugZabofloxacin 367mg

    Zabofloxacin 367mg single dose

    Also known as: Zabolante 367mg

06

What researchers measure

Primary outcomes

  1. Cmax and AUC

    Maximum of Concentration(Cmax) Area Under Plasma Concentration-Time Curve(AUC)

    Time frame: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

Secondary outcomes

  1. Pharmacokinetic Profile of Plasma

    Maximum drug concentration time(Tmax) Half-time(t1/2) Apparent renal clearance(CL/F) Apparent volume of distribution(Vz/F) Mean of Retention Time(MRT)

    Time frame: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

  2. Pharmacokinetic Profile of Urine

    Umax, Cumulative Amount Excreted(Ae), Fraction of the dose excreted unchanged(fe), Renal Clearance(CLr), Urinary Hydrogen exponent(Urinary pH)

    Time frame: Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours

  3. Bactericidal Activity Profile of Urine

    Urinary Bactericidal Titers(UBT) Area under the UBT-versus-time curve(AUBT)

    Time frame: Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours

07

Study locations

1 site
  • Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 561-712, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02212795
Lead sponsor
Dong Wha Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Aug 8, 2014
Start date
May 2014
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Jun 29, 2015

Study contacts

MinGul Kim, M.D
principal investigator · Chonbuk National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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