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NCT02699658 Clinical Trial

Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02699658
Other study ID # Levo-57-356141
Secondary ID
Status Completed
Phase Phase 2
First received February 24, 2016
Last updated March 3, 2016
Start date October 2013
Est. completion date September 2014

Study information
Verified date February 2016
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee, Faculty of Medicine, Prince of Songkla University
Study type Interventional

Clinical Trial Summary

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:

1. reveal the population pharmacokinetics, and

2. 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%.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 45 Years
Eligibility Inclusion:

- normal hematologic

- normal hepatic

- normal renal functions

- non-smoking

- non-alcoholic

- non-obese

Exclusion:

- pregnant or lactating women

- any chronic medications

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Levofloxacin

Locations
Country Name City State
Thailand Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University Hat Yai Songkla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary concentration of levofloxacin in plasma up to 2 week after blood collection No
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