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Randomized two-way cross-over bioequivalence study of two amoxicillin formulations and inter-ethnicity pharmacokinetic variation in healthy Malay volunteers.
- Source :
-
Biomedical chromatography : BMC [Biomed Chromatogr] 2014 Sep; Vol. 28 (9), pp. 1246-53. Date of Electronic Publication: 2014 Mar 03. - Publication Year :
- 2014
-
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.<br /> (Copyright © 2014 John Wiley & Sons, Ltd.)
- Subjects :
- Adult
Amoxicillin blood
Amoxicillin chemistry
Area Under Curve
Blood Pressure drug effects
Chromatography, High Pressure Liquid
Cross-Over Studies
Drug Stability
Heart Rate drug effects
Humans
Malaysia epidemiology
Male
Random Allocation
Reproducibility of Results
Sensitivity and Specificity
Therapeutic Equivalency
Young Adult
Amoxicillin adverse effects
Amoxicillin pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 1099-0801
- Volume :
- 28
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Biomedical chromatography : BMC
- Publication Type :
- Academic Journal
- Accession number :
- 24585432
- Full Text :
- https://doi.org/10.1002/bmc.3153