A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 supp

2014 ◽  
Vol 16 ◽  
pp. 36-50 ◽  
Author(s):  
D. Bell ◽  
A. Duffin ◽  
A. Jacobs ◽  
C. Pediconi ◽  
H. J. Gruss
Keyword(s):  
Healthy Volunteers ◽  
Repeat Dose ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Pharmacodynamic Effects ◽  
Parallel Group ◽  
Dose Study ◽  
Repeat Dose Study ◽  
Dose Escalating

scholarly journals Safety and Pharmacokinetics of Multiple 750-Milligram Doses of Intravenous Levofloxacin in Healthy Volunteers

2001 ◽  
Vol 45 (7) ◽  
pp. 2122-2125 ◽  
Author(s):  
Andrew T. Chow ◽  
Cynthia Fowler ◽  
R. Rex Williams ◽  
Nancy Morgan ◽  
Susan Kaminski ◽  
...  
Keyword(s):  
Intensive Care ◽  
Healthy Volunteers ◽  
Intravenous Dose ◽  
Clinical Settings ◽  
Single Center ◽  
Double Blind ◽  
Time Curve ◽  
Once Daily ◽  
Concentration Time ◽  
Parallel Group

ABSTRACT The safety and pharmacokinetics of a once-daily high intravenous dose of levofloxacin (750 mg) in 18 healthy volunteers were studied in a double-blind, randomized, placebo-controlled, single-center parallel group study. Levofloxacin was well tolerated, and higher maximum concentration of drug in serum and area under the concentration-time curve values were achieved. For difficult-to-treat infections, high daily doses of levofloxacin may be beneficial, and intravenous administration may be preferred in certain clinical settings, such as when treating patients in intensive care units, warranting further evaluation.

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