Bioequivalence of Two Commercial Amoxicillin Suspensions

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.

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.