NCT01933698

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

August 20, 2013

Last Update Submit

August 28, 2013

Conditions

Bioequivalence of Amoxicillin

Keywords

BioequivalenceAmoxicillinHuman

Outcome Measures

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.

    Change from baseline to 12 hours

Study Arms (2)

Amoxi-Ped

ACTIVE COMPARATOR

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

Drug: amoxicillin

Amoxil

ACTIVE COMPARATOR

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

Drug: amoxicillin

Interventions

amoxicillinDRUG

Comparison of pharmacokinetics of both formulations

Also known as: Amoxil, Amoxi-Ped
Amoxi-PedAmoxil

Eligibility Criteria

Age19 Years - 46 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIOAGRI Laboratórios Ltda

Piracicaba, São Paulo, 13412-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 16035378BACKGROUND

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Francisco C Groppo, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

  • Ana PP Cione, Chem.

    BIOAGRI Laboratórios Ltda

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

August 20, 2013

First Posted

September 2, 2013

Study Start

February 1, 2005

Primary Completion

May 1, 2005

Study Completion

July 1, 2005

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations

BR(1)