ClinicalTrials.gg
CompletedNCT01933698Updated Sep 2, 2013

Bioequivalence of Two Commercial Amoxicillin Suspensions

A Phase 4 interventional study of amoxicillin in Bioequivalence of Amoxicillin, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 19 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-02.

Sponsored by University of Campinas, Brazil · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years to 46 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Bioequivalence of Amoxicillin

Keywords

  • Bioequivalence
  • Amoxicillin
  • Human
03

In context

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 168 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 46 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Amoxi-Ped

    Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast.

    Drug: amoxicillin

  • Active comparator
    Amoxil

    Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast.

    Drug: amoxicillin

Interventions

  • Comparison of pharmacokinetics of both formulations

    Also known as: Amoxil, Amoxi-Ped

06

What researchers measure

Primary outcomes

  1. Changes in plasmatic amoxicillin concentrations along time measured by HPLC.

    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.

    Time frame: Change from baseline to 12 hours

07

Study locations

1 site
  • BIOAGRI Laboratórios Ltda
    Piracicaba, São Paulo 13412-000, Brazil
08

References and documents

Publications

  • Baglie S, Rosalen PL, Franco LM, Ruenis AP, Baglie RC, Franco GC, Silva P, Groppo FC. Comparative bioavailability of 875 mg amoxicillin tablets in healthy human volunteers. Int J Clin Pharmacol Ther. 2005 Jul;43(7):350-4. doi: 10.5414/cpp43350. PubMed 16035378 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01933698
Responsible party
Francisco Groppo (Full Professor, University of Campinas, Brazil) — Principal investigator
First posted
Sep 2, 2013
Start date
Feb 2005
Primary completion
May 2005
Completion
Jul 2005
Last update
Sep 2, 2013

Study contacts

Francisco C Groppo, PhD
principal investigator · University of Campinas, Brazil
Ana PP Cione, Chem.
study chair · BIOAGRI Laboratórios Ltda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Amoxicillin

Start the discussion