Clinical trial NCT01341249: A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong Wha Pharmaceutical Co. Ltd.
First posted: 2011-04-25
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).


Eligibility 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

Primary outcomes:
measure: Cmax of zabofloxacin in plasma
timeFrame: Up to 48
measure: AUClast of zabofloxacin in plasma
timeFrame: Up to 48
Secondary outcomes:
measure: Tmax of zabofloxacin in plasma
timeFrame: Up to 48h
measure: terminal half-life (t1/2) of zabofloxacin in plasma
timeFrame: Up to 48h
measure: CL/F of zabofloxacin in plasma
timeFrame: Up to 48h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.