Pharmacokinetics and bioequivalence of thiamphenicol capsules
XU Chu-hong
Abstract
XU Chu-hong
Abstract
Objective;To assess the pharmacokinetic profiles and bioequivalenee of thiampheni- col capsules.Methods;Eighteen healthy male volunteers were randomly administered with a single cross- over oral dose of test and reference thiamphenicol(0.5 g).The serum concentration of thiamphenicol from the volunteers was measured by HPLC to evaluate the pharmacokinetic parameters and relative bio- availability.Results;The main pharmacokinetic parameters of test and reference thiamphenicol were as follows;AUC_(0-t)(34.91±5.33)vs.(33.73±6.09) mg·h·L~(-1);AUC_(0-∞)(37.00±5.74)vs.(35. 64±6.50)mg·h·L~(-1);C_(max)(6.84±1.25)vs.(6.48±1.58) mg·L~(-1);T_(max)(1.75±0.68)vs.(1. 96±0.78)h and t_(1/2)(3.66±0.55)vs.(3.69±0.68)h.The relative bioavailability of test thiam- phenicol capsules was(105.32±39.75)%.Conclusion:The test thiamphenicol is bioequivalent to the reference thiamphenicol.
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Objective;To assess the pharmacokinetic profiles and bioequivalenee of thiampheni- col capsules.Methods;Eighteen healthy male volunteers were randomly administered with a single cross- over oral dose of test and reference thiamphenicol(0.5 g).The serum concentration of thiamphenicol from the volunteers was measured by HPLC to evaluate the pharmacokinetic parameters and relative bio- availability.Results;The main pharmacokinetic parameters of test and reference thiamphenicol were as follows;AUC_(0-t)(34.91±5.33)vs.(33.73±6.09) mg·h·L~(-1);AUC_(0-∞)(37.00±5.74)vs.(35. 64±6.50)mg·h·L~(-1);C_(max)(6.84±1.25)vs.(6.48±1.58) mg·L~(-1);T_(max)(1.75±0.68)vs.(1. 96±0.78)h and t_(1/2)(3.66±0.55)vs.(3.69±0.68)h.The relative bioavailability of test thiam- phenicol capsules was(105.32±39.75)%.Conclusion:The test thiamphenicol is bioequivalent to the reference thiamphenicol.
Key concepts: Thiamphenicol, Bioequivalence, Pharmacokinetics, Bioavailability, Oral dose, Pharmacology, Medicine, Chemistry