Trial Condition(s):
Anti-Infective Agents
Cross over study to prove bioequivalence between two brands of cefalexin suspension
Bayer Identifier:
15188
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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 abuse tobacco or alcohol 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Clinica de Enfermedades Cronicas y Procedimientos Especiales Morelia, Mexico, 58256 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective, randomized, open label, crossover study to compare the bioavailability between Optocef 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 under fasting conditions
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Least square estimator of average maximum plasmatic concentration (log transformed)Timeframe: After two months
- Least square estimator of area under the pharmacokinetic curve (log transformed)Timeframe: After two months
Secondary Outcome
- Time at which maximum concentration is reachedTimeframe: After two months
- Area under the pharmacokinetic curve from time=0 to last blood sampleTimeframe: After two months
- Clearance constant of plasmatic concentrations of study drugTimeframe: After two months
- Half life of plasmatic concentration of study drugTimeframe: After two months
- Adverse events collectionTimeframe: Up to 6 weeks
Additional Information
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