A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation
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|ClinicalTrials.gov Identifier: NCT00601432|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: levofloxacin oral solution||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomized, 2-way Crossover Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||December 2002|
- Evaluation of the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing.
- Safety was assessed through vital sign monitoring, physicals, laboratory tests, and urinalysis on Days 1 and 3 and through the monitoring of adverse events throughout the study.
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): NCT00601432
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|