A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Experimental DW224aa; Drug: Experimental DW224a

• Registration Number: NCT01341249
• Lead Sponsor: Seoul National University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Primary Completion: 2011-05
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DW224aa	Experimental DW224aa	DW224aa given by oral administration
DW224a	Experimental DW224a	DW224aa given by oral administration

Primary Outcome Measures

Name	Time	Method
Cmax of zabofloxacin in plasma	Up to 48
AUClast of zabofloxacin in plasma	Up to 48

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Trials Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of