The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.
A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1 x 500 mg) under fed conditions. The washout period will be at least 14 days between doses. Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five (23 + 2) subjects completed the clinical portion of the study in its entirety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
26
MDS Pharma Services
Montreal, Quebec, Canada
Bioequivalence
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