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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
25
Comparison of pharmacokinetics of both formulations
BIOAGRI Laboratórios Ltda
Piracicaba, São Paulo, Brazil
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.
Time frame: Change from baseline to 12 hours
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