Anti-Infective Agents
Conditions
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.
Interventions
DRUGCephalexin suspension (Optocef, BAYO5448)
Single dose of 500 mg / 10 mL
Single dose of 500 mg / 20 mL
Sponsors
Corporación Bonima S.A. de C.V.
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clearance constant of plasmatic concentration of study drug | After two months |
| Time at which maximum concentration is reached | After two months |
| Adverse events collection | Up to 6 weeks |
| Half life of plasmatic concentration of study drug | After two months |
| Area under the pharmacokinetic curve from time=0 to last blood sample | After two months |
Countries
Mexico
Outcome results
None listed