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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anti-Infective Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Cephalexin suspension (Optocef, BAYO5448)

Intervention Type DRUG

Single dose of 500 mg / 10 mL

Arm 2

Group Type ACTIVE_COMPARATOR

Cephalexin suspension (Keflex)

Intervention Type DRUG

Single dose of 500 mg / 20 mL

Interventions

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Cephalexin suspension (Optocef, BAYO5448)

Single dose of 500 mg / 10 mL

Intervention Type DRUG

Cephalexin suspension (Keflex)

Single dose of 500 mg / 20 mL

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes