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

This study has been completed.
Sponsor:
Collaborator:
Corporación Bonima S.A. de C.V.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01073553
First received: February 22, 2010
Last updated: April 1, 2014
Last verified: April 2014

February 22, 2010
April 1, 2014
October 2009
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After two month ] [ Designated as safety issue: No ]
  • Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After two month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01073553 on ClinicalTrials.gov Archive Site
  • 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 concentration 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 six weeks ] [ Designated as safety issue: Yes ]
  • Time at which maximum concentration is reached [ Time Frame: After two month ] [ Designated as safety issue: No ]
  • Area under the pharmacokinetic curve from time=0 to last blood sample [ Time Frame: After two month ] [ Designated as safety issue: No ]
  • Clearance constant of plasmatic concentration of study drug [ Time Frame: After two month ] [ Designated as safety issue: No ]
  • Half life of plasmatic concentration of study drug [ Time Frame: After two month ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: Up to six weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Anti-Infective Agents
  • Drug: Cephalexin capsules (Optocef, BAYO5448 )
    Single dose of 500 mg (One 500 mg capsule)
  • Drug: Cephalexin capsules (Keflex)
    Single dose of 500 mg (Two 250 mg capsules)
  • Experimental: Arm 1
    Intervention: Drug: Cephalexin capsules (Optocef, BAYO5448 )
  • Active Comparator: Arm 2
    Intervention: Drug: Cephalexin capsules (Keflex)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01073553
14784
No
Bayer
Bayer
Corporación Bonima S.A. de C.V.
Study Director: Bayer Study Director Bayer
Bayer
April 2014

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