check_circleStudy Completed

Anti-Infective Agents

Bayer Identifier:

14784

ClinicalTrials.gov Identifier:

NCT01073553

EudraCT Number:

Not Available

EU CT Number:

Not Available
Cross-over study to prove bioequivalence between two brands of cefalexin capsules

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
26
Trial Dates
October 2009 - October 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Optocef (Cephalexin capsules, BAYO5448)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Clinica de Enfermedades Cronicas y Procedimientos EspecialesMorelia, 58256, Mexico

Primary Outcome

  • Least square estimator of average maximum plasmatic concentration (log transformed)
    date_rangeTime Frame:
    After two months
    enhanced_encryption
    Safety Issue:
    no
  • Least square estimator of area under the pharmacokinetic curve (log transformed)
    date_rangeTime Frame:
    After two months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Time at which maximum concentration is reached
    date_rangeTime Frame:
    After two months
    enhanced_encryption
    Safety Issue:
    no
  • Area under the pharmacokinetic curve from time=0 to last blood sample
    date_rangeTime Frame:
    After two months
    enhanced_encryption
    Safety Issue:
    no
  • Clearance constant of plasmatic concentration of study drug
    date_rangeTime Frame:
    After two months
    enhanced_encryption
    Safety Issue:
    no
  • Half life of plasmatic concentration of study drug
    date_rangeTime Frame:
    After two months
    enhanced_encryption
    Safety Issue:
    no
  • Adverse events collection
    date_rangeTime Frame:
    Up to six weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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