NCT01933698

Bioequivalence of Two Commercial Amoxicillin Suspensions

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 19 Years – 46 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence of Amoxicillin

Interventions

Type	Name	Description
DRUG	amoxicillin	Comparison of pharmacokinetics of both formulations

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-05-01
• Completion: 2005-07-01
• First posted: 2013-09-02
• Last updated: 2013-09-02

Locations

1 site across 1 country: Brazil