Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin (Bacteriocide)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212795
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: Zabofloxacin 183mg Drug: Levofloxacin 250mg Drug: Zabofloxacin 367mg Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Phase I Study of Pharmacokinetics and Bacteriocidal Activity
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Zabofloxacin 183mg single dose
Other Name: Zabolante 183mg

Drug: Levofloxacin 250mg
Levofloxacin 250mg single dose
Other Name: Cravit

Drug: Zabofloxacin 367mg
Zabofloxacin 367mg single dose
Other Name: Zabolante 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
Zabofloxacin 183mg single dose
Other Name: Zabolante 183mg

Drug: Levofloxacin 250mg
Levofloxacin 250mg single dose
Other Name: Cravit

Drug: Zabofloxacin 367mg
Zabofloxacin 367mg single dose
Other Name: Zabolante 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
Zabofloxacin 183mg single dose
Other Name: Zabolante 183mg

Drug: Levofloxacin 250mg
Levofloxacin 250mg single dose
Other Name: Cravit

Drug: Zabofloxacin 367mg
Zabofloxacin 367mg single dose
Other Name: Zabolante 367mg




Primary Outcome Measures :
  1. Cmax and AUC [ Time Frame: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours ]
    Maximum of Concentration(Cmax) Area Under Plasma Concentration-Time Curve(AUC)


Secondary Outcome Measures :
  1. Pharmacokinetic Profile of Plasma [ Time Frame: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours ]
    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)

  2. Pharmacokinetic Profile of Urine [ Time Frame: Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours ]
    Umax, Cumulative Amount Excreted(Ae), Fraction of the dose excreted unchanged(fe), Renal Clearance(CLr), Urinary Hydrogen exponent(Urinary pH)

  3. Bactericidal Activity Profile of Urine [ Time Frame: Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours ]
    Urinary Bactericidal Titers(UBT) Area under the UBT-versus-time curve(AUBT)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

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): NCT02212795


Locations
Layout table for location information
Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Investigators
Layout table for investigator information
Principal Investigator: MinGul Kim, M.D Chonbuk National University Hospital

Layout table for additonal information
Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02212795     History of Changes
Other Study ID Numbers: DW224-I-7
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: February 2015
Keywords provided by Dong Wha Pharmaceutical Co. Ltd.:
healthy
Additional relevant MeSH terms:
Layout table for MeSH terms
Levofloxacin
Ofloxacin
Fluoroquinolones
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors