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Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions

2014-08-27 03:26:45 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

cefprozil 500mg tablets

Location

MDS Pharma Services
Montreal
Quebec
Canada
H4R2N6

Status

Completed

Source

Ranbaxy Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:45-0400

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