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OpenTrials
Completed

NCT Number: NCT01073553

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

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.

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Key information

Conditions

Anti-Infective Agents

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Morelia, Michoacán, 58256, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cephalexin capsules (Optocef, BAYO5448 )

Drug

Single dose of 500 mg (One 500 mg capsule)

Cephalexin capsules (Keflex)

Drug

Single dose of 500 mg (Two 250 mg capsules)

Primary outcomes

  1. Least square estimator of average maximum plasmatic concentration (log transformed)

    Time frame: After two months

  2. Least square estimator of area under the pharmacokinetic curve (log transformed)

    Time frame: After two months

Secondary outcomes

  1. Time at which maximum concentration is reached

    Time frame: After two months

  2. Area under the pharmacokinetic curve from time=0 to last blood sample

    Time frame: After two months

  3. Clearance constant of plasmatic concentration of study drug

    Time frame: After two months

  4. Half life of plasmatic concentration of study drug

    Time frame: After two months

  5. Adverse events collection

    Time frame: Up to six weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Corporación Bonima S.A. de C.V.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2010
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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