2009Chinese Journal of PharmaceuticalsRequires access

Pharmacokinetics and Bioavailability of Granisetron Hydrochloride Tablets in Healthy Volunteers

Zhong Li-li

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Abstract

The pharmacokinetics of granisetron hydrochloride orally disintegrating tablets (test preparation) and its related bioavailability to granisetron hydrochloride tablets (reference preparation) are discussed. According a single dose crossover design,20 healthy volunteers were administrated with 1mg of test and reference preparations. The plasma concentrations were determined by HPLC-fluorescence detector. The pharmacokinetic parameters of the test and reference preparations were as follows:cmax (3.32±0.93) and (3.20±0.86) ng/ml,tmax (1.65±0.52) and (1.88±0.86) h,t1/2 (6.16±0.90) and (6.22±0.81) h,AUC0→t (19.50±8.10) and (19.70±7.78) ng·h·ml-1,AUC0→∞ (20.90±9.11) and (21.10± 8.57) ng·h·ml-1. The relative bioavailability of the test preparation was (99.8±15.3)%. The result showed that the two preparations were bioequivalent.

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What this paper is about

The pharmacokinetics of granisetron hydrochloride orally disintegrating tablets (test preparation) and its related bioavailability to granisetron hydrochloride tablets (reference preparation) are discussed. According a single dose crossover design,20 healthy volunteers were administrated with 1mg of test and reference preparations. The plasma concentrations were determined by HPLC-fluorescence detector. The pharmacokinetic parameters of the test and reference preparations were as follows:cmax (3.32±0.93) and (3.20±0.86) ng/ml,tmax (1.65±0.52) and (1.88±0.86) h,t1/2 (6.16±0.90) and (6.22±0.81) h,AUC0→t (19.50±8.10) and (19.70±7.78) ng·h·ml-1,AUC0→∞ (20.90±9.11) and (21.10± 8.57) ng·h·ml-1. The relative bioavailability of the test preparation was (99.8±15.3)%. The result showed that the two preparations were bioequivalent.

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Available abstract

The pharmacokinetics of granisetron hydrochloride orally disintegrating tablets (test preparation) and its related bioavailability to granisetron hydrochloride tablets (reference preparation) are discussed. According a single dose crossover design,20 healthy volunteers were administrated with 1mg of test and reference preparations. The plasma concentrations were determined by HPLC-fluorescence detector. The pharmacokinetic parameters of the test and reference preparations were as follows:cmax (3.32±0.93) and (3.20±0.86) ng/ml,tmax (1.65±0.52) and (1.88±0.86) h,t1/2 (6.16±0.90) and (6.22±0.81) h,AUC0→t (19.50±8.10) and (19.70±7.78) ng·h·ml-1,AUC0→∞ (20.90±9.11) and (21.10± 8.57) ng·h·ml-1. The relative bioavailability of the test preparation was (99.8±15.3)%. The result showed that the two preparations were bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Pharmacokinetics, Chemistry, Cmax, Pharmacology, Granisetron, High-performance liquid chromatography

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