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

Phase 1

Completed

• Conditions: Anti-Infective Agents
• Interventions: Drug: Cephalexin suspension (Optocef, BAYO5448); Drug: Cephalexin suspension (Keflex)

• Registration Number: NCT01073540
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Cephalexin suspension (Optocef, BAYO5448)	-
Arm 2	Cephalexin suspension (Keflex)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events collection	Up to 6 weeks
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