Bioequivalence of Two Commercial Amoxicillin Suspensions

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Campinas, Brazil
• Collaborator: Stiefel, a GSK Company
• Treatments: Amoxicillin

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.