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Bioequivalence of Two Commercial Amoxicillin Suspensions

NCT01933698 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-09-02

No results posted yet for this study

Summary

The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.

Conditions

  • Bioequivalence of Amoxicillin

Interventions

DRUG

amoxicillin

Comparison of pharmacokinetics of both formulations

Sponsors & Collaborators

  • Stiefel, a GSK Company

    collaborator INDUSTRY

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Francisco C Groppo, PhD · University of Campinas, Brazil

  • Ana PP Cione, Chem. · BIOAGRI Laboratórios Ltda

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
46 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2005-05-31
Completion
2005-07-31

Countries

  • Brazil

Study Locations

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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 NCT01933698 on ClinicalTrials.gov