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

NCT01073540 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-04-03

No results posted yet for this study

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.

Conditions

  • Anti-Infective Agents

Interventions

DRUG

Cephalexin suspension (Optocef, BAYO5448)

Single dose of 500 mg / 10 mL

DRUG

Cephalexin suspension (Keflex)

Single dose of 500 mg / 20 mL

Sponsors & Collaborators

  • Corporación Bonima S.A. de C.V.

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073540 on ClinicalTrials.gov