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Pharmacokinetics and bioavailability of ondansetron hydrochloride tablets in healthy volunteers

Qian Wang

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Abstract

Objective To establish an HPLC method for determining the content of ondansetron hydrochloride,and discuss the bioavailability of it with the reference preparation of ondansetron hydrochloride tablets.Methods 20 healthy volunteers were administered with 8 mg of test preparation or reference preparation randomly.The plasma concentration was determined by RP-HPLC method,to study the pharmacokinetics and relative bioavailability.Results The pharmacokinetic parameters of test and reference preparations were as follows:Cmax:(48.21±0.34)and(46.30±18.77)ng/mL;AUC0-t:(203.48±56.80)and(206.03±53.60)ng · h/mL;AUC0-∞:(223.24±55.74)and(227.14±55.59)ng · h/mL;t1/2:(4.39±1.75)and(4.22±1.27)h.The relative bioavailability of test preparation was 101.1%±0.2%.Conclusion The two preparations were bioequivalent.

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What this paper is about

Objective To establish an HPLC method for determining the content of ondansetron hydrochloride,and discuss the bioavailability of it with the reference preparation of ondansetron hydrochloride tablets.Methods 20 healthy volunteers were administered with 8 mg of test preparation or reference preparation randomly.The plasma concentration was determined by RP-HPLC method,to study the pharmacokinetics and relative bioavailability.Results The pharmacokinetic parameters of test and reference preparations were as follows:Cmax:(48.21±0.34)and(46.30±18.77)ng/mL;AUC0-t:(203.48±56.80)and(206.03±53.60)ng · h/mL;AUC0-∞:(223.24±55.74)and(227.14±55.59)ng · h/mL;t1/2:(4.39±1.75)and(4.22±1.27)h.The relative bioavailability of test preparation was 101.1%±0.2%.Conclusion The two preparations were bioequivalent.

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Available abstract

Objective To establish an HPLC method for determining the content of ondansetron hydrochloride,and discuss the bioavailability of it with the reference preparation of ondansetron hydrochloride tablets.Methods 20 healthy volunteers were administered with 8 mg of test preparation or reference preparation randomly.The plasma concentration was determined by RP-HPLC method,to study the pharmacokinetics and relative bioavailability.Results The pharmacokinetic parameters of test and reference preparations were as follows:Cmax:(48.21±0.34)and(46.30±18.77)ng/mL;AUC0-t:(203.48±56.80)and(206.03±53.60)ng · h/mL;AUC0-∞:(223.24±55.74)and(227.14±55.59)ng · h/mL;t1/2:(4.39±1.75)and(4.22±1.27)h.The relative bioavailability of test preparation was 101.1%±0.2%.Conclusion The two preparations were bioequivalent.

Key concepts: Bioavailability, Bioequivalence, Cmax, Pharmacokinetics, Ondansetron, Pharmacology, High-performance liquid chromatography, Chromatography

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