Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin

NCT02212795 | Completed Phase 1 DMC

• 1 other identifier: DW224-I-7
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

healthy

Outcome Measures

Primary Outcomes (1)

• Cmax and AUC

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

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

Secondary Outcomes (3)

• Pharmacokinetic Profile of Plasma

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

• Pharmacokinetic Profile of Urine

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

• Bactericidal Activity Profile of Urine

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

Study Arms (3)

A Group

EXPERIMENTAL

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

B Group

EXPERIMENTAL

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

C Group

EXPERIMENTAL

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

Zabofloxacin 183mg DRUG

Zabofloxacin 183mg single dose

Also known as: Zabolante 183mg

A Group; B Group; C Group

Levofloxacin 250mg DRUG

Levofloxacin 250mg single dose

Also known as: Cravit

A Group; B Group; C Group

Zabofloxacin 367mg DRUG

Zabofloxacin 367mg single dose

Also known as: Zabolante 367mg

A Group; B Group; C Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

MeSH Terms

Interventions

zabofloxacin; Levofloxacin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• MinGul Kim, M.D

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: August 8, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 29, 2015

Record last verified: 2015-02

Locations

KR (1)