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A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

This study has been completed.
Sponsor:
Collaborator:
Dong Wha Pharmaceutical Co. Ltd.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01341249
First received: April 20, 2011
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Experimental DW224aa
Drug: Experimental DW224a
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official 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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Cmax of zabofloxacin in plasma [ Time Frame: Up to 48 ] [ Designated as safety issue: No ]
  • AUClast of zabofloxacin in plasma [ Time Frame: Up to 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax of zabofloxacin in plasma [ Time Frame: Up to 48h ] [ Designated as safety issue: No ]
  • terminal half-life (t1/2) of zabofloxacin in plasma [ Time Frame: Up to 48h ] [ Designated as safety issue: No ]
  • CL/F of zabofloxacin in plasma [ Time Frame: Up to 48h ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DW224aa
DW224aa given by oral administration
 Drug: Experimental DW224aa
DW224aa tablet, single dose
Active Comparator: DW224a
DW224aa given by oral administration
 Drug: Experimental DW224a
DW224a capsule, single dose

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341249

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Dong Wha Pharmaceutical Co. Ltd.
Investigators
Principal Investigator: Kyung Sang Yu, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chang-Soo Cho, DONG WHA PHARMACEUTICAL CO., LTD
ClinicalTrials.gov Identifier: NCT01341249     History of Changes
Other Study ID Numbers: SNUCPT11_DW224aa
Study First Received: April 20, 2011
Last Updated: July 15, 2011
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013