Healthy
Conditions
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).
Interventions
DRUGExperimental DW224aa
DW224aa tablet, single dose
DRUGExperimental DW224a
DW224a capsule, single dose
Sponsors
Dong Wha Pharmaceutical Co. Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of zabofloxacin in plasma | Up to 48 |
| AUClast of zabofloxacin in plasma | Up to 48 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed