Bioequivalence of Amoxicillin
Conditions
Keywords
Bioequivalence, Amoxicillin, Human
Brief 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.
Detailed description
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.
Interventions
DRUGamoxicillin
Comparison of pharmacokinetics of both formulations
Sponsors
Stiefel, a GSK Company
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 46 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasmatic amoxicillin concentrations along time measured by HPLC. | Change from baseline to 12 hours | 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. |
Countries
Brazil
Outcome results
None listed