NCT01105208

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

Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef 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 Under Fasting Conditions

• 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: 2010-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-04-16
• Last updated: 2014-05-20

Locations

1 site across 1 country: Mexico