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

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

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

Study Overview

• Status: Completed
• Conditions: Anti-Infective Agents
• Intervention / Treatment: Drug: Cephalexin suspension (Optocef, BAYO5448 ); Drug: Cephalexin suspension (Keflex)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Michoacán
    • Morelia, Michoacán, Mexico, 58256

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Cephalexin suspension (Keflex); Single dose of 500 mg / 20 mL
Experimental: Arm 1	Drug: Cephalexin suspension (Optocef, BAYO5448 ); Single dose of 500 mg / 10 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 concentrations of study drug	After two months
Half life of plasmatic concentration of study drug	After two months
Adverse events collection	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Corporación Bonima S.A. de C.V.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cephalexin
• Other Study ID Numbers: 15188; Biocef-S (Other Identifier: Company Internal)