A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

NCT01341249 | Completed Phase 1

• 1 other identifier: SNUCPT11_DW224aa
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the main component of DW224aa(Test drug) and DW224a(Reference drug).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax of zabofloxacin in plasma

  Up to 48

• AUClast of zabofloxacin in plasma

  Up to 48

Secondary Outcomes (3)

• Tmax of zabofloxacin in plasma

  Up to 48h

• terminal half-life (t1/2) of zabofloxacin in plasma

  Up to 48h

• CL/F of zabofloxacin in plasma

  Up to 48h

Study Arms (2)

DW224aa

EXPERIMENTAL

DW224aa given by oral administration

Drug: Experimental DW224aa

DW224a

ACTIVE COMPARATOR

DW224aa given by oral administration

Drug: Experimental DW224a

Interventions

Experimental DW224aa DRUG

DW224aa tablet, single dose

DW224aa

Experimental DW224a DRUG

DW224a capsule, single dose

DW224a

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a healthy adult male within the range of 20 to 45 years old at the time of screening
• one with weight of more than 55kg, in the range of IBW 20%
• IBW(kg)={height(cm)-100}\*0.9
• one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

You may not qualify if:

• one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
• one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
• one who is allergic or has clinically significant allergic history to the quinolone antibiotics, or to other drugs(Aspirin, antibiotics, etc)
• one who shows the following result in clinical laboratory test: AST,ALT\>1.25 times of the upper limit of normal range
• one who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
• one who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
• one who has participated in other clinical study within 2 months before study drug administration
• one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
• one who drank Over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
• one who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization
• one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
• one with clinically significant observations considered as unsuitable based on medical judgment by investigators

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Dong Wha Pharmaceutical Co. Ltd.: collaborator

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Han H, Kim SE, Shin KH, Lim C, Lim KS, Yu KS, Cho JY. Comparison of pharmacokinetics between new quinolone antibiotics: the zabofloxacin hydrochloride capsule and the zabofloxacin aspartate tablet. Curr Med Res Opin. 2013 Oct;29(10):1349-55. doi: 10.1185/03007995.2013.825591. Epub 2013 Aug 19.

  PMID: 23865727 DERIVED

Study Officials

• Kyung Sang Yu, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 25, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2011
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

KR (1)