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Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules

2014-08-27 03:15:43 | BioPortfolio

Summary

A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Anti-Infective Agents

Intervention

Cephalexin capsules (Optocef, BAY O5448 ), Cephalexin capsules (Keflex)

Location

Morelia
Mexico
58256

Status

Completed

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:43-0400

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Medical and Biotech [MESH] Definitions

An envelope of loose gel surrounding a bacterial cell which is associated with the virulence of pathogenic bacteria. Some capsules have a well-defined border, whereas others form a slime layer that trails off into the medium. Most capsules consist of relatively simple polysaccharides but there are some bacteria whose capsules are made of polypeptides.

Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.

Long-acting, broad-spectrum, water-soluble, CEPHALEXIN derivative.

A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.

Hard or soft soluble containers used for the oral administration of medicine.

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