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
NCT00602589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2016-12-22
Summary
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.
Conditions
- Healthy
Interventions
- DRUG
-
Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
Sponsors & Collaborators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2002-10-31
- Completion
- 2002-11-30
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