check_circleStudy Completed

Anti-Infective Agents

Bayer Identifier:

14783

ClinicalTrials.gov Identifier:

NCT01073540

EudraCT Number:

Not Available

EU CT Number:

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

Trial purpose

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.

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
September 2009 - September 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Optocef (Cephalexin suspension, 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 6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Prospective, randomized, open label, crossover study to compare the bioavailability between Optocef suspension 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
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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