Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin
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|ClinicalTrials.gov Identifier: NCT02699658|
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a broad spectrum of activity. In common with other fluoroquinolones, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy is the area under the plasma time-concentration curve/the minimum inhibitory concentration ratios.
The aims of the study were to:
- reveal the population pharmacokinetics, and
- assess the efficacy of various dosage regimens in achieving the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral levofloxacin was prescribed as the switching therapy after intravenous levofloxacin treatment.
The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens were predicted to achieve CFR greater than or equal to 90%.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Levofloxacin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
|Experimental: levofloxacin in healthy||
- concentration of levofloxacin in plasma [ Time Frame: up to 2 week after blood collection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699658
|Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University|
|Hat Yai, Songkla, Thailand, 90110|