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Randomized two‐way cross‐over bioequivalence study of two amoxicillin formulations and inter‐ethnicity pharmacokinetic variation in healthy Malay volunteers
Author(s) -
Liew Kai Bin,
Loh Gabriel Onn Kit,
Tan Yvonne Tze Fung,
Peh Kok Khiang
Publication year - 2014
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.3153
Subject(s) - bioequivalence , cmax , pharmacokinetics , crossover study , amoxicillin , confidence interval , chemistry , population , malay , coefficient of variation , high performance liquid chromatography , pharmacology , chromatography , medicine , placebo , antibiotics , biochemistry , linguistics , alternative medicine , philosophy , environmental health , pathology
The objectives of this study were to develop a new deproteinization method to extract amoxicillin from human plasma and evaluate the inter‐ethnic variation of amoxicillin pharmacokinetics in healthy Malay volunteers. A single‐dose, randomized, fasting, two‐period, two‐treatment, two‐sequence crossover, open‐label bioequivalence study was conducted in 18 healthy Malay adult male volunteers, with one week washout period. The drug concentration in the sample was analyzed using high‐performance liquid chromatography (UV–vis HPLC). The mean (standard deviation) pharmacokinetic parameter results of Moxilen® were: peak concentration ( C max ), 6.72 (1.56) µg/mL; area under the concentration–time graph (AUC 0–8 ), 17.79 (4.29) µg/mL h; AUC 0–∞ , 18.84 (4.62) µg/mL h. Those of YSP Amoxicillin® capsule were: C max , 6.69 (1.44) µg/mL; AUC 0–8 , 18.69 (3.78) µg/mL h; AUC0 0–∞ , 19.95 (3.81) µg/mL h. The 90% confidence intervals for the logarithmic transformed C max , AUC 0–8 and AUC 0–∞ of Moxilen® vs YSP Amoxicillin® capsule was between 0.80 and 1.25. Both C max and AUC met the predetermined criteria for assuming bioequivalence. Both formulations were well tolerated. The results showed significant inter‐ethnicity variation in pharmacokinetics of amoxicillin. The C max and AUC of amoxicillin in Malay population were slightly lower compared with other populations. Copyright © 2014 John Wiley & Sons, Ltd.