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

This study has been completed.
Sponsor:
Collaborator:
Corporación Bonima S.A. de C.V.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01105208
First received: April 12, 2010
Last updated: May 19, 2014
Last verified: May 2014

April 12, 2010
May 19, 2014
March 2010
March 2010   (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 ]
Same as current
Complete list of historical versions of study NCT01105208 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 concentrations 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 6 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
  • Clearence constant of plasmatic concentrations of study drug [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Half life of plasmatic concentration of study druge [ Time Frame: After two months ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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 suspension (Optocef, BAYO5448 )
    Single dose of 500 mg / 10 mL
  • Drug: Cephalexin suspension (Keflex)
    Single dose of 500 mg / 20 mL
  • Experimental: Arm 1
    Intervention: Drug: Cephalexin suspension (Optocef, BAYO5448 )
  • Active Comparator: Arm 2
    Intervention: Drug: Cephalexin suspension (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
March 2010
March 2010   (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 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01105208
15188, Biocef-S
No
Bayer
Bayer
Corporación Bonima S.A. de C.V.
Study Director: Bayer Study Director Bayer
Bayer
May 2014

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