Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

This study has been completed.

Sponsor:

Collaborator:

Corporación Bonima S.A. de C.V.

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01105208

First received: April 12, 2010

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2010

Last Updated Date

May 16, 2013

Start Date ^ICMJE

March 2010

Primary Completion Date

March 2010 (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 ] [ Designated as safety issue: No ]
Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After two months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01105208 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time at which maximum concentration is reached [ Time Frame: After two months ] [ Designated as safety issue: No ]
Area under the pharmacokinetic curve from time=0 to last blood sample [ Time Frame: After two months ] [ Designated as safety issue: No ]
Clearance constant of plasmatic concentrations of study drug [ Time Frame: After two months ] [ Designated as safety issue: No ]
Half life of plasmatic concentration of study drug [ Time Frame: After two months ] [ Designated as safety issue: No ]
Adverse events collection [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Time at which maximum concentration is reached [ Time Frame: After two months ] [ Designated as safety issue: No ]
Area under the pharmacokinetic curve from time=0 to last blood sample [ Time Frame: After two months ] [ Designated as safety issue: No ]
Clearence constant of plasmatic concentrations of study drug [ Time Frame: After two months ] [ Designated as safety issue: No ]
Half life of plasmatic concentration of study druge [ Time Frame: After two months ] [ Designated as safety issue: No ]
Adverse events collection [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]

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 Suspension

Official Title ^ICMJE

Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef 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 Under Fasting Conditions

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anti-Infective Agents

Intervention ^ICMJE

Drug: Cephalexin suspension (Optocef, BAYO5448 )
Single dose of 500 mg / 10 mL
Drug: Cephalexin suspension (Keflex)
Single dose of 500 mg / 20 mL

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Cephalexin suspension (Optocef, BAYO5448 )
Active Comparator: Arm 2
Intervention: Drug: Cephalexin suspension (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

March 2010

Primary Completion Date

March 2010 (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 abuse tobacco or alcohol 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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT01105208

Other Study ID Numbers ^ICMJE

15188, Biocef-S

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer de Mexico S.A. de C.V.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Corporación Bonima S.A. de C.V.

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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