A Phase 1 interventional study of Zabofloxacin 183mg and Levofloxacin 250mg in Healthy, sponsored by Dong Wha Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-29.
Sponsored by Dong Wha Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Health services research
Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer
A Randomized, open label, single dose, crossover phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer
Dong Wha Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1st oral administration of Zabofloxacin 183mg, 2nd oral administration of Zabofloxacin 367mg and 3rd oral administration of Levofloxacin 250mg
Drug: Zabofloxacin 183mg · Drug: Levofloxacin 250mg · Drug: Zabofloxacin 367mg
1st oral administration of Zabofloxacin 367mg, 2nd oral administration of Levofloxacin 250mg and 3rd oral administration of Zabofloxacin 367mg
Drug: Zabofloxacin 183mg · Drug: Levofloxacin 250mg · Drug: Zabofloxacin 367mg
1st oral administration of Levofloxacin 250mg, 2nd oral administration of Zabofloxacin 183mg and 3rd oral administration of Zabofloxacin 367mg
Drug: Zabofloxacin 183mg · Drug: Levofloxacin 250mg · Drug: Zabofloxacin 367mg
Zabofloxacin 183mg single dose
Also known as: Zabolante 183mg
Levofloxacin 250mg single dose
Also known as: Cravit
Zabofloxacin 367mg single dose
Also known as: Zabolante 367mg
Cmax and AUC
Maximum of Concentration(Cmax) Area Under Plasma Concentration-Time Curve(AUC)
Time frame: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Pharmacokinetic Profile of Plasma
Maximum drug concentration time(Tmax) Half-time(t1/2) Apparent renal clearance(CL/F) Apparent volume of distribution(Vz/F) Mean of Retention Time(MRT)
Time frame: Predose(0), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Pharmacokinetic Profile of Urine
Umax, Cumulative Amount Excreted(Ae), Fraction of the dose excreted unchanged(fe), Renal Clearance(CLr), Urinary Hydrogen exponent(Urinary pH)
Time frame: Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours
Bactericidal Activity Profile of Urine
Urinary Bactericidal Titers(UBT) Area under the UBT-versus-time curve(AUBT)
Time frame: Predose(-12-0), 0-6, 6-12, 12-24, 24-36, 48-72, 72-96, 96-120 hours
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Dong Wha Pharmaceutical Co. Ltd.