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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef Suspension 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

Conditions
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Anti-Infective Agents

Intervention / Treatment
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* Drug: Cephalexin suspension (Optocef, BAYO5448)
* Drug: Cephalexin suspension (Keflex)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Cephalexin suspension (Optocef, BAYO5448)<br>* Single dose of 500 mg / 10 mL<br>|
| Active Comparator: Arm 2<br> | Drug: Cephalexin suspension (Keflex)<br>* Single dose of 500 mg / 20 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least square estimator of average maximum plasmatic concentration (log transformed) |  | After two months | 
| Least square estimator of area under the pharmacokinetic curve (log transformed) |  | After two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which maximum concentration is reached |  | After two months | 
| Area under the pharmacokinetic curve from time=0 to last blood sample |  | After two months | 
| Clearance constant of plasmatic concentration of study drug |  | After two months | 
| Half life of plasmatic concentration of study drug |  | After two months | 
| Adverse events collection |  | Up to 6 weeks |