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

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

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.

Study Overview

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Cephalexin capsules (Keflex); Single dose of 500 mg (Two 250 mg capsules)
Experimental: Arm 1	Drug: Cephalexin capsules (Optocef, BAYO5448 ); Single dose of 500 mg (One 500 mg capsule)

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
Half life of plasmatic concentration of study drug	After two months
Clearance constant of plasmatic concentration of study drug	After two months
Adverse events collection	Up to six weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cephalexin
• Other Study ID Numbers: 14784