Study on the bioequivalence of thiamphenicol
enteric-coated micro pills capsules in healthy volunteers
GE Miao-miao,HUANG Lu,SHU Cheng-ren,LI Wei-yong(Institute of
Clinic Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of
Science & Technology,Hubei Wuhan 430022,China)
OBJECTIVE To study the pharmacokinetics of thiamphenicol
enteric-coated micro pills capsules in healthy volunteers and evaluate the
bioequivalence of two different preparations of thiamphenicol.METHODS Single
oral dose of 0.5 g thiamphenicol enteric-coated micro pills capsules and
tablets were given to 18 volunteers in an open randomized crossover way.The
concentrations of thiamphenic-ol(TAP) in plasma were determined by
high-performance liquid chromatography.The pharmacokinetic parameters were
calculated and the bioequivalence of two formulations were evaluated by DAS
program.RESULTS The main pharmacokinetic parameters of test and reference
preparations obtained from single oral dose were as follows: tmax
were(3.8±0.5)h、(4.3±1.0)h;t1/2 were(5.4±1.2)h、(5.7±1.9)h.Cmax were(4.1±1.3)mg·L-1、(3.9±1.5)mg·L-1;AUC0→t
were(28.7±8.1)mg·h·L-1、(30.5±10.4)mg·h·L-1;AUC0→∞ were(30.7±8.7)mg·h·L-1、(33.3±11.9)mg·h·L-1.The
relative bioavailability of test formulation was(98.7±26.2)%.CONCLUSION The two
preparations are bioequivalent.
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