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

Tracking Information
First Submitted Date ICMJE	February 22, 2010
First Posted Date ICMJE	February 23, 2010
Last Update Posted Date	April 3, 2015
Study Start Date ICMJE	October 2009
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 22, 2010)	Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After two months ]; Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After two months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01073553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 22, 2010)	Time at which maximum concentration is reached [ Time Frame: After two months ]; Area under the pharmacokinetic curve from time=0 to last blood sample [ Time Frame: After two months ]; Clearance constant of plasmatic concentration of study drug [ Time Frame: After two months ]; Half life of plasmatic concentration of study drug [ Time Frame: After two months ]; Adverse events collection [ Time Frame: Up to six weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Anti-Infective Agents
Intervention ICMJE	Drug: Cephalexin capsules (Optocef, BAYO5448 ) Single dose of 500 mg (One 500 mg capsule); Drug: Cephalexin capsules (Keflex) Single dose of 500 mg (Two 250 mg capsules)
Study Arms	Experimental: Arm 1 Intervention: Drug: Cephalexin capsules (Optocef, BAYO5448 ); Active Comparator: Arm 2 Intervention: Drug: Cephalexin capsules (Keflex)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 22, 2010)	26
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2009
Actual Primary Completion Date	October 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Mexico
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01073553
Other Study ID Numbers ICMJE	14784
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor ICMJE	Bayer
Collaborators ICMJE	Corporación Bonima S.A. de C.V.
Investigators ICMJE	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	April 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP