Bioequivalence of clarithromycin tablets in Chinese healthy subjects
WANG Hua-wei
LI Xiao-bin
CAO Ying
SUI Xin
CHEN Lu
DOU Xiao-yan
NI Feng
SHEN Wen-jing
LIU Ying
WANG Wen-ping
Abstract：Objective:To evaluate the bioequivalence of clarithromycin tablets in healthy Chinese subjects.Methods:Two separate studies were conducted—a fasting study and a fed study—each involving 52 healthy subjects.Both studies employed a two-period,complete repetition,and self-crossover design.Subjects received a single oral dose(0.25 g)of either the test or reference clarithromycin tablet.The plasma concentrations of clarithromycin were determined using Liquid chromatography-mass spectrometry(LC-MS).Pharmacokinetic parameters and relative bioavailability were calculated with WinNonlin8.1 software to assess bioequivalence between the two preparations.Results:Under fasting conditions,the main pharmacokinetics parameters(mean±SD)for the test and reference preparations were as follows:Cmax(1 219.26±446.14)vs(1 179.41±473.28)ng·mL-1;AUC0-t(6 285.38±2 021.53)vs(6 311.37±2 212.95)h·ng·mL-1;AUC0-∞(6 453.49±2 041.59)vs(6619.14±2335.67)h·ng·mL-1.Under fed conditions,the corresponding values were:Cmax(1 587.32±628.76)vs(1492.28±573.62)ng·mL-1;AUC0-t(7053.24±2436.54)vs(6714.95±2193.32)h·ng·mL-1;AUC0-∞(7 253.08±2 510.36)vs(6 959.44±2 206.17)h·ng·mL-1.The 90%confidence intervals for the geometric mean ratios of Cmax,AUC0-t,and AUC0-∞ for both fasting and fed studies fell entirely within theaccepted bioequivalence range of 80.00%～125.00%.Conclusion:The test and reference clarithromycin tablets are bioequivalent in healthy Chinese subjects under fasting and fed conditions.
Keywords：clarithromycinbioequivalenceLC-MS
Publication Date：2026-01-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 59-63 )