check_circleStudy Completed
Anti-Infective Agents
Bayer Identifier:
14783
ClinicalTrials.gov Identifier:
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
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
26Trial Dates
September 2009 - September 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Optocef (Cephalexin suspension, BAYO5448)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Clinica de Enfermedades Cronicas y Procedimientos Especiales | Morelia, 58256, Mexico |
Primary Outcome
- Least square estimator of average maximum plasmatic concentration (log transformed)date_rangeTime Frame:After two monthsenhanced_encryptionnoSafety Issue:
- Least square estimator of area under the pharmacokinetic curve (log transformed)date_rangeTime Frame:After two monthsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Time at which maximum concentration is reacheddate_rangeTime Frame:After two monthsenhanced_encryptionnoSafety Issue:
- Area under the pharmacokinetic curve from time=0 to last blood sampledate_rangeTime Frame:After two monthsenhanced_encryptionnoSafety Issue:
- Clearance constant of plasmatic concentration of study drugdate_rangeTime Frame:After two monthsenhanced_encryptionnoSafety Issue:
- Half life of plasmatic concentration of study drugdate_rangeTime Frame:After two monthsenhanced_encryptionnoSafety Issue:
- Adverse events collectiondate_rangeTime Frame:Up to 6 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2