Trial Condition(s):
Anti-Infective Agents
Cross-over study to prove bioequivalence between two brands of cefalexin capsules
Bayer Identifier:
14784
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
A single dose, two treatments (two cephalexin capsules 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 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
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 (Cephalexin 500 mg capsules) from Bayer and Keflex (Cephalexin 250 mg capsules) from Eli Lilly po in healthy subjects using equivalent concentrations
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 concentration of study drugTimeframe: After two months
- Half life of plasmatic concentration of study drugTimeframe: After two months
- Adverse events collectionTimeframe: Up to six weeks
Additional Information
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