A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

Seoul National University

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Experimental DW224a

Drug: Experimental DW224aa

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01341249

SNUCPT11_DW224aa

Details and patient eligibility

About

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

Enrollment

32 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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