NCT01073553

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

Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef (Cephalexin 500 mg Capsules) From Bayer and Keflex (Cephalexin 250 mg Capsules) From Eli Lilly po in Healthy Subjects Using Equivalent Concentrations

• 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 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.

Conditions

• Anti-Infective Agents

Interventions

Type	Name	Description
DRUG	Cephalexin capsules (Optocef, BAYO5448 )	Single dose of 500 mg (One 500 mg capsule)
DRUG	Cephalexin capsules (Keflex)	Single dose of 500 mg (Two 250 mg capsules)

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2010-02-23
• Last updated: 2015-04-03

Locations

1 site across 1 country: Mexico