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Levofloxacin; Levofloxacin; and Levofloxacin marketed formulations

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Dec 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Levofloxacin; Levofloxacin; and Levofloxacin marketed formulations · 1 trial · 1 indication

Phase 1 1
NCT00602589A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy SubjectsHealthy
COMPLETED72 Analytics
PHASE1COMPLETED
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
Healthy
NCT0060258972
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Study Endpoints

Primary Endpoints

Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference.

Secondary Endpoints

Assessment of the bioequivalence of the oral suspension and solution formulations, on Days 1, 2, and 3, using the suspension formulation as the reference.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulationsDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Men and women * Aged 18 to 55 years * BMI between 18 and 30 kg/m2 * No prescription or over-the-counter medications for previous 14 days * Negative tests for drug and alcohol abuse, HIV, hepatitis B and hepatitis C * and Healthy based on medical history, physical examination, ...

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