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

This study has been completed.

Sponsor:

Collaborator:

Corporación Bonima S.A. de C.V.

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01073553

First received: February 22, 2010

Last updated: April 2, 2015

Last verified: April 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2010

Last Updated Date

April 2, 2015

Start Date ^ICMJE

October 2009

Primary Completion Date

October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

Completion Date

October 2009

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

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

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