Bioequivalence of Two Commercial Amoxicillin Suspensions

August 28, 2013 updated by: Francisco Groppo, University of Campinas, Brazil

Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0h) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2, Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations for both formulations in each subject.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Piracicaba, SP, Brazil, 13412-000
        • BIOAGRI Laboratórios Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy test for women
  • age between 19 and 46 years
  • weight between 52 and 85 kg and body mass index between 17.6 and 28.4kg/m2
  • ability to provide written consent
  • laboratory exam results within the normal range for healthy individuals and/or medically acceptable defined by a clinical investigator;
  • feeding habits consistent with the standardization of the study

Exclusion Criteria:

  • pregnancy
  • history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)
  • any evidence of dysfunction or clinically significant deviation from normal
  • history of any psychiatric illness that might compromise the ability to provide written consent
  • history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular, hematological, neurological or diabetes or glaucoma
  • active smoker
  • consumption of more than 5 cups of coffee or tea per day
  • history of drug dependence or abuse of alcohol consumption
  • use of enzymatic-inducers drugs within 30 days or any systemic medication (including prescription drugs, such as painkillers, hepatoprotective, influenza, etc) within 14 days before the start of the study
  • participation in any clinical study in 9 weeks prior to the study
  • have lost or donated more than 350 mL of blood in the last three months
  • have been subjected to abnormal diet for any reason (therapeutic, aesthetic, religious, etc.)
  • did not have adequate venous access.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amoxi-Ped
Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast.
Drug: amoxicillin
Comparison of pharmacokinetics of both formulations
Other Names:
  • Amoxil
  • Amoxi-Ped
Active Comparator: Amoxil
Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast.
Drug: amoxicillin
Comparison of pharmacokinetics of both formulations
Other Names:
  • Amoxil
  • Amoxi-Ped

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
Time Frame: Change from baseline to 12 hours
Amoxicillin were extracted from plasma by precipitating plasma proteins with acetonitrile. Amoxicillin plasmatic concentration was accessed every 30 minutes until 3h hours after drug administration and every 2h after this time until 12h of drug administration. Drug plasmatic concentrations were obtained by using a HPLC method.
Change from baseline to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Stiefel, a GSK Company

Investigators

  • Principal Investigator: Francisco C Groppo, PhD, University of Campinas, Brazil
  • Study Chair: Ana PP Cione, Chem., BIOAGRI Laboratórios Ltda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMOXIPED-01
  • 63.064.653/0001-54 (Other Grant/Funding Number: LABORATÓRIOS STIEFEL LTDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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