Bioequivalence of Two Commercial Amoxicillin Suspensions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers

Conditions
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Bioequivalence of Amoxicillin

Intervention / Treatment
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* Drug: amoxicillin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxi-Ped<br>Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast. | Drug: amoxicillin<br>* Comparison of pharmacokinetics of both formulations<br>* Other names: Amoxi-Ped;|
| Active Comparator: Amoxil<br>Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast. | Drug: amoxicillin<br>* Comparison of pharmacokinetics of both formulations<br>* Other names: Amoxi-Ped;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Amoxicillin, Human