Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01073553

Enrollment

Registered

2010-02-23

Start date

2009-10-31

Completion date

2009-10-31

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Infective Agents

Brief summary

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.

Interventions

DRUGCephalexin capsules (Keflex)

Single dose of 500 mg (Two 250 mg capsules)

DRUGCephalexin capsules (Optocef, BAYO5448 )

Single dose of 500 mg (One 500 mg capsule)

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 six 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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026