NCT02699658

Brief 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. 1.reveal the population pharmacokinetics, and
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 healthy-volunteers

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
Last Updated

March 4, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

February 24, 2016

Last Update Submit

March 3, 2016

Conditions

Healthy Volunteers

Keywords

levofloxacinpopulation pharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • concentration of levofloxacin in plasma

    up to 2 week after blood collection

Study Arms (1)

levofloxacin in healthy

EXPERIMENTAL
Drug: Levofloxacin

Interventions

LevofloxacinDRUG
levofloxacin in healthy

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal hematologic
  • normal hepatic
  • normal renal functions
  • non-smoking
  • non-alcoholic
  • non-obese

You may not qualify if:

  • pregnant or lactating women
  • any chronic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prince of Songkla University

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 4, 2016

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

March 4, 2016

Record last verified: 2016-02

Locations

TH(1)