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Arzneimittelforschung 2011; 61(9): 502-505
DOI: 10.1055/s-0031-1296234
Antiemetics · Gastrointestinal Drugs · Urologic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Bioequivalence study of two esomeprazole enteric coated formulations in healthy Chinese volunteers

Wei Cai
1   Department of General Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China
2   Department of Pharmacy, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China
,
Zheng-ting Wang
3   Department of Gastroenterology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China
,
Juan Li
2   Department of Pharmacy, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China
,
Jia-jia Hu
2   Department of Pharmacy, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China
,
Jie Zhong
3   Department of Gastroenterology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China
› Author Affiliations
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Publication History

Publication Date:
03 December 2011 (online)

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Abstract

A bioequivalence study of two esomeprazole (CAS 119141-88-7) enteric-coated formulations was carried out in 20 healthy Chinese volunteers according to a single dose, two-sequence, crossover randomized design. The two formulations were administered in two treatment days, separated by a washout period of 7 days. Blood samples were collected at specified time intervals over 10 h post-dosing. Plasma samples were separated and assayed for esomeprazole using a selective and sensitive HPLC method with UV detection. The pharmacokinetic parameters AUC0–12h, AUCmax, Cmax, t max, t 1/2 and MRT were determined from the plasma concentration-time profile of both formulations. ANOVA and two one-sided t-test procedures showed no significant difference in log-transformed Cmax, AUC0–12h and AUC0–∞ while the 90% confidence interval (CI) of the ratio of the geometric means of their values were also used to assess bioequivalence between the two formulations. The results of this study indicated that the two esomeprazole formulations can be considered to be bioequivalent.

Key words

Bioequivalence - Esomeprazole - Pharmacokinetics - Proton pump inhibitor
 

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