ScholarLens Back to search
2002•Journal of Jiangsu Clinical MedicineRequires access

STUDY ON BIOEQUIVALENCE OF CETIRIZINE HYDROCHLORIDE TABLETS

Fang Guo-ron

Open publisher page 0 citations

Abstract

Objective:To study the bioequivalence of Hydrochloride Tablets in healthy volunteers.Methods: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 sensitive HPLC assay was modified for determination of the drug levels in plasma.Results:The t max of tablets A and B were (1 72±0 39)h and (1 65±0 55)h,the C max (613±121 7)ng/ml and (597±119 8)ng/ml,(11 5±2 7)h and (12 0±2 9)h,AUC 0～24 (2 855 1±528 3)h·ng/ml and (3 016 4±702 8)h·ng/ml,respectively,and t1/2(11 5±2 7)h and (12 0±2 9)h.The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is no significant difference between the two products.Conclution:These two products are bioequivalent.

About this research paper

What this paper is about

Objective:To study the bioequivalence of Hydrochloride Tablets in healthy volunteers.Methods: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 sensitive HPLC assay was modified for determination of the drug levels in plasma.Results:The t max of tablets A and B were (1 72±0 39)h and (1 65±0 55)h,the C max (613±121 7)ng/ml and (597±119 8)ng/ml,(11 5±2 7)h and (12 0±2 9)h,AUC 0～24 (2 855 1±528 3)h·ng/ml and (3 016 4±702 8)h·ng/ml,respectively,and t1/2(11 5±2 7)h and (12 0±2 9)h.The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is no significant difference between the two products.Conclution:These two products are bioequivalent.

Why it matters

A significance statement is not available in the OpenAlex record.

Key contribution

A contribution statement is not available in the OpenAlex record.

Method / approach

Method details are not available in the OpenAlex metadata.

Main findings

Findings are not separately available in the OpenAlex metadata.

Limitations

Limitations are not available in the OpenAlex metadata.

Applications

Application details are not available in the OpenAlex metadata.

Available abstract

Objective:To study the bioequivalence of Hydrochloride Tablets in healthy volunteers.Methods: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 sensitive HPLC assay was modified for determination of the drug levels in plasma.Results:The t max of tablets A and B were (1 72±0 39)h and (1 65±0 55)h,the C max (613±121 7)ng/ml and (597±119 8)ng/ml,(11 5±2 7)h and (12 0±2 9)h,AUC 0～24 (2 855 1±528 3)h·ng/ml and (3 016 4±702 8)h·ng/ml,respectively,and t1/2(11 5±2 7)h and (12 0±2 9)h.The mean relative bioavailability of the tablets B vs A was (100 2±7 4)%.There is no significant difference between the two products.Conclution:These two products are bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Medicine, Crossover study, Chromatography, Pharmacology, Plasma concentration, Hydrochloride

Related papers

Related paper 1Related paper 2Related paper 3
Back to paper searchBrowse research topicsOriginal source
STUDY ON BIOEQUIVALENCE OF CETIRIZINE HYDROCHLORIDE TABLETS — Research Paper | ScholarLens