Trial Condition(s):

Anti-Infective Agents

Cross-over study to prove bioequivalence between two brands of cefalexin suspension

Bayer Identifier:

14783

ClinicalTrials.gov Identifier:

NCT01073540

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
26
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Optocef (Cephalexin suspension, BAYO5448)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Clinica de Enfermedades Cronicas y Procedimientos Especiales

Morelia, Mexico, 58256

Status
Completed
 

Trial Design