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Bioequivalence of Two Commercial Amoxicillin Suspensions
Bioequivalence of Two Commercial Amoxicillin Suspensions

NCT01933698

CompletedPhase 4

Sponsor: University of Campinas, Brazil

Conditions: Bioequivalence of Amoxicillin

Interventions: amoxicillin

Countries: Brazil

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.

Eligibility overview

Sex: ALL

Age: 19 Years to 46 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Piracicaba, São Paulo, Brazil