title: Randomized two-way cross-over bioequivalence study of two amoxicillin formulations and inter-ethnicity pharmacokinetic variation in healthy Malay volunteers.
abstract: 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 (Cmax ), 6.72 (1.56) µg/mL; area under the concentration-time graph (AUC0-8 ), 17.79 (4.29) µg/mL h; AUC0-∞ , 18.84 (4.62) µg/mL h. Those of YSP Amoxicillin® capsule were: Cmax , 6.69 (1.44) µg/mL; AUC0-8 , 18.69 (3.78) µg/mL h; AUC00-∞ , 19.95 (3.81) µg/mL h. The 90% confidence intervals for the logarithmic transformed Cmax , AUC0-8 and AUC0-∞ of Moxilen® vs YSP Amoxicillin® capsule was between 0.80 and 1.25. Both Cmax 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 Cmax and AUC of amoxicillin in Malay population were slightly lower compared with other populations.
authors.affiliation: School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia.
authors.forename: Kai Bin
authors.initials: KB
authors.lastname: Liew
authors.forename: Gabriel Onn Kit
authors.initials: GO
authors.lastname: Loh
authors.forename: Yvonne Tze Fung
authors.initials: YT
authors.lastname: Tan
authors.forename: Kok Khiang
authors.initials: KK
authors.lastname: Peh
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000009:adverse effects* / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001794:Blood Pressure / Q000187:drug effects; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004355:Drug Stability; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D011897:Random Allocation; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000658:Amoxicillin
keywords: HPLC; YSP amoxicillin capsule; amoxicillin; bioequivalence; moxilen