Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
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
1 other identifier
interventional
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedApril 3, 2014
April 1, 2014
Same day
February 22, 2010
April 1, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Least square estimator of average maximum plasmatic concentration (log transformed)
After two months
Least square estimator of area under the pharmacokinetic curve (log transformed)
After two months
Secondary Outcomes (5)
Time at which maximum concentration is reached
After two months
Area under the pharmacokinetic curve from time=0 to last blood sample
After two months
Clearance constant of plasmatic concentration of study drug
After two months
Half life of plasmatic concentration of study drug
After two months
Adverse events collection
Up to 6 weeks
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Corporación Bonima S.A. de C.V.collaborator
Study Sites (1)
Unknown Facility
Morelia, Michoacán, 58256, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 23, 2010
Study Start
September 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
April 3, 2014
Record last verified: 2014-04