A Phase 4 interventional study of amoxicillin in Bioequivalence of Amoxicillin, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 19 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-02.
Sponsored by University of Campinas, Brazil · Phase 4, Interventional, and Basic science
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.
University of Campinas, Brazil is the lead sponsor of 168 studies on the registry; 13 are open to participants now.
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Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast.
Drug: amoxicillin
Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast.
Drug: amoxicillin
Comparison of pharmacokinetics of both formulations
Also known as: Amoxil, Amoxi-Ped
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
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amoxicillin
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