Pharmacokinetic Study of Amoxicillin Capsule in Healthy Bangladeshi Subjects using Urinary Excretion Data

Abstract

The aim of the study was to compare the urinary excretion data and bioavailability of two 500 mg
amoxicillin capsules formulations in healthy Bangladeshi subjects under fasting condition and evaluate the ethnic
variations in drug disposition. Twenty-four subjects were enrolled into this single-dose, randomized, open-label, twoway
cross over study. A washout period of one week was allowed between two treatments. Following oral
administration, urine samples were collected at different time intervals and were analyzed using a validated HPLC
method with UV detection. The pharmacokinetic parameters for two formulations were calculated by noncompartmental
method using the software Kinetica and statistical analysis was done for the evaluation of
bioequivalence. The pharmacokinetic analysis indicated that the kinetic disposition of two formulations was similar.
This was evident when the mean (± standard deviation) values of the various pharmacokinetic parameters were
compared. No significant difference between two formulations was found when analyzed by paired t-test and
ANOVA. Therefore it can be concluded that the test product (SK-mox®) is bioequivalent to the reference product
(Amoxil-Bencard®) based on the US FDA's regulatory definition. Moreover, an ethnic variation was obs