Overview

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:
CorporaciĆ³n 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