NCT01073540

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

Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef Suspension From Bayer (Cephalexin Suspension 250 mg/5 mL) and Equivalent Concentration of Keflex Pediatrico From Eli Lilly (Cephalexin Suspension 125 mg/5mL) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anti-Infective Agents

Interventions

Type	Name	Description
DRUG	Cephalexin suspension (Optocef, BAYO5448)	Single dose of 500 mg / 10 mL
DRUG	Cephalexin suspension (Keflex)	Single dose of 500 mg / 20 mL

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2010-02-23
• Last updated: 2014-04-03

Locations

1 site across 1 country: Mexico