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Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

2014-08-27 03:14:32 | BioPortfolio

Summary

A single dose, two treatments (two cephalexin suspension 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 suspension (Optocef, BAYO5448 ), Cephalexin suspension (Keflex)

Location

Morelia
Michoacán
Mexico
58256

Status

Completed

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:32-0400

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Medical and Biotech [MESH] Definitions

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.

A readily reversible suspension of sensorimotor interaction with the environment, usually associated with recumbency and immobility.

A suspension of metallic gold particles.

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