Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef (Cephalexin 500 mg Capsules) From Bayer and Keflex (Cephalexin 250 mg Capsules) From Eli Lilly po in Healthy Subjects Using Equivalent Concentrations
Sponsor study identifier
interventional
26
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Actual (reported)Study Completion
October 2009
Actual (reported)A single dose, two treatments (two cephalexin capsules 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 2009
Actual (reported)October 2009
Actual (reported)February 22, 2010
Actual (reported)February 23, 2010
Actual (reported)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
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 six weeks
Single dose of 500 mg (One 500 mg capsule)
Single dose of 500 mg (Two 250 mg capsules)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Morelia, Michoacán, 58256, Mexico
Bayer Study Director
Bayer
26 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2010
First Posted
February 23, 2010
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Compliance of Initial Empiric Antimicrobial Therapy
Contact the study team to confirm eligibility.
Primary Completion
October 2009
Actual (reported)Study Completion
October 2009
Actual (reported)Last Updated
April 3, 2015
Record last verified: 2015-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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