Bioequivalence of Two Commercial Amoxicillin Suspensions

University of Campinas, Brazil

Status and phase

Completed

Phase 4

Conditions

Bioequivalence of Amoxicillin

Treatments

Drug: amoxicillin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01933698

AMOXIPED-01

63.064.653/0001-54 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

19 to 46 years old

Volunteers

Accepts Healthy Volunteers

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.