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