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

Authors

  • Md Ashik Ullah Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka
  • Mohammad Abul Kalam Azad Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka
  • Rebeka Sultana Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka
  • Eva Rahman Kabir Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka
  • AHM Mahbub Latif Institute of Statistical Research and Training, University of Dhaka, Dhaka
  • Abul Hasnat Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka

DOI:

https://doi.org/10.3329/dujps.v8i1.5336

Keywords:

Amoxicillin, pharmacokinetics, Bangladeshi subjects

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 observed
following 64.34% cumulative urinary recovery of amoxicillin over 12 hours when compared with other studies.

Key words: Amoxicillin; pharmacokinetics; Bangladeshi subjects.

DOI: 10.3329/dujps.v8i1.5336

Dhaka Univ. J. Pharm. Sci. 8(1): 53-59, 2009 (June)

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How to Cite

Ullah, M. A., Azad, M. A. K., Sultana, R., Kabir, E. R., Latif, A. M., & Hasnat, A. (2010). Pharmacokinetic Study of Amoxicillin Capsule in Healthy Bangladeshi Subjects using Urinary Excretion Data. Dhaka University Journal of Pharmaceutical Sciences, 8(1), 53–59. https://doi.org/10.3329/dujps.v8i1.5336

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