Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01073553
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bacterial Capsules
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.
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.
Capsules
Hard or soft soluble containers used for the oral administration of medicine.
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...
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...
Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than c...
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by CA-MRSA. The investigators hypothesize that treatment with ceph...
The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.
PubMed Articles
Selection of CMY-2 producing Escherichia coli in the faecal flora of dogs treated with cephalexin.
Cephalexin is a first generation cephalosporin commonly used in dogs for treatment of pyoderma. The objective of this study was to evaluate the in vivo effects of cephalexin on selection of Escherichi...
The pharmacokinetic profile and bioavailability of a long-acting formulation of cephalexin after intramuscular administration to cats was investigated. Single intravenous (cephalexin lysine salt) and...
Coralline calcium-hydroxyapatite and calcium carbonate from Porites Porites coral were added to a polymeric matrix based on polyvinyl acetate (POVIAC(®)), to obtain a novel bone substitute composite...
The Effect of Staggered Administration of Zinc Sulfate on the Pharmacokinetics of Oral Cephalexin*
"What this paper adds statement": a) What is already known about the subject: • Zinc supplementation is an important intervention against mortality from infectious disease. • Many patients using z...
Highly fluorescent M(2)L(4) molecular capsules with anthracene shells.
M(2)L(4) molecular capsules self-assembled from M(ii) ions (where M = Zn, Ni, and Pd) and bent bidentate ligands constructed from anthracene fluorophores. The Ni(ii) and Zn(ii) capsules exhibited weak...
