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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Collaborator: Corporación Bonima S.A. de C.V.
• Treatments: Cephalexin

Criteria

Inclusion Criteria:

• Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

• History of illnesses or any organic abnormalities that could affect the results of the study

• History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs

• Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup