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

Anti-Infective Agents Clinical Trial

Official title:

Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef Suspension 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073540
• Other study ID #: 14783
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2010
• Last updated: April 1, 2014
• Start date: September 2009
• Est. completion date: September 2009

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anti-Infective Agents

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Corporación Bonima S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least square estimator of average maximum plasmatic concentration (log transformed)		After two months	No
Primary	Least square estimator of area under the pharmacokinetic curve (log transformed)		After two months	No
Secondary	Time at which maximum concentration is reached		After two months	No
Secondary	Area under the pharmacokinetic curve from time=0 to last blood sample		After two months	No
Secondary	Clearance constant of plasmatic concentration of study drug		After two months	No
Secondary	Half life of plasmatic concentration of study drug		After two months	No
Secondary	Adverse events collection		Up to 6 weeks	Yes

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