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Completed

NCT Number: NCT01341249

A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

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

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Center, Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
  • 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

Treatment and study plan

Experimental DW224aa

Drug

DW224aa tablet, single dose

Experimental DW224a

Drug

DW224a capsule, single dose

Primary outcomes

  1. Cmax of zabofloxacin in plasma

    Time frame: Up to 48

  2. AUClast of zabofloxacin in plasma

    Time frame: Up to 48

Secondary outcomes

  1. Tmax of zabofloxacin in plasma

    Time frame: Up to 48h

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

    Time frame: Up to 48h

  3. CL/F of zabofloxacin in plasma

    Time frame: Up to 48h

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong Wha Pharmaceutical Co. Ltd.

Registry information

Official study title

Clinical Trial to Compare the Pharmacokinetic Profiles of DW224aa (Aspartate) Tablet and DW224a (Hydrochloride) Capsule After a Single Oral Administration in Healthy Male Volunteers

Important dates

Study start
2011
Primary completion
2011
First posted
Apr 25, 2011
Registry last updated
Jul 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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