Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01105208
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cefaclor
Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.
Cefadroxil
Long-acting, broad-spectrum, water-soluble, CEPHALEXIN derivative.
Cephalexin
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.
Sleep
A readily reversible suspension of sensorimotor interaction with the environment, usually associated with recumbency and immobility.
Gold Colloid
A suspension of metallic gold particles.
Clinical Trials
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
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 balance...
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