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Study on bioequivalence of Getirizine Hydrochloride Tablets

Haijian Chen

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Abstract

Objective To study the bioequivalence Hydrochloride Tablets in healthy voIunteers Method In a randomized two way crossover design . 20mg single dose tablets A and B were respectively given to 10 male healthy volunteers.A rapid and senccitive HPLC assay was modified for determination of the drug levels in plasma Results The tmax,t1/2 and AUC0 24 of tablets A and B were (1 72±0 39)h and (1 65±0 55)h, (6 13±121 7)ng/ ml and (597±119 8)ng/ml, (11 5±2 7)h and(12 0±2 9)h, (2855 1±528 3)h/(ng ml) and (3016 4±702 8)h /(ng ml), respectively,The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is on signiticaant difference between the two products Concolusions The results suggested that these two products wete bioequivalent.

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What this paper is about

Objective To study the bioequivalence Hydrochloride Tablets in healthy voIunteers Method In a randomized two way crossover design . 20mg single dose tablets A and B were respectively given to 10 male healthy volunteers.A rapid and senccitive HPLC assay was modified for determination of the drug levels in plasma Results The tmax,t1/2 and AUC0 24 of tablets A and B were (1 72±0 39)h and (1 65±0 55)h, (6 13±121 7)ng/ ml and (597±119 8)ng/ml, (11 5±2 7)h and(12 0±2 9)h, (2855 1±528 3)h/(ng ml) and (3016 4±702 8)h /(ng ml), respectively,The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is on signiticaant difference between the two products Concolusions The results suggested that these two products wete bioequivalent.

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Available abstract

Objective To study the bioequivalence Hydrochloride Tablets in healthy voIunteers Method In a randomized two way crossover design . 20mg single dose tablets A and B were respectively given to 10 male healthy volunteers.A rapid and senccitive HPLC assay was modified for determination of the drug levels in plasma Results The tmax,t1/2 and AUC0 24 of tablets A and B were (1 72±0 39)h and (1 65±0 55)h, (6 13±121 7)ng/ ml and (597±119 8)ng/ml, (11 5±2 7)h and(12 0±2 9)h, (2855 1±528 3)h/(ng ml) and (3016 4±702 8)h /(ng ml), respectively,The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is on signiticaant difference between the two products Concolusions The results suggested that these two products wete bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Medicine, Crossover study, Hydrochloride, Chromatography, Pharmacology, High-performance liquid chromatography

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