Arzneimittelforschung 2008; 58(8): 385-388
DOI: 10.1055/s-0031-1296525
Antiemetics · Gastrointestinal Drugs · Urologic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Bio equivalence Study of Two Capsule Formulations of Omeprazole in Healthy Volunteers

Alessandro Allegrini
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Loredana Nuzzo
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Andrea Tavella Scaringi
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Stefano Felaco
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Daniele Pavone
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Elena Toniato
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Andrea Mezzetti
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Stefano Martinotti
1   Clinical Research Centre, Centre of Excellence on Aging, “G. D’Annunzio” University Foundation, Chieti, Italy
,
Giuseppina Lenotti
2   Errekappa Euroterapici S.p.A., Milan, Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
15 December 2011 (online)

Abstract

The study was conducted in order to assess the bioequivalence of two capsule formulations (test and reference) containing 20 mg of omeprazole (5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulfinyl]-lH-benzimidazole, CAS 73590-58-6). Fifty healthy male and female volunteers were treated in a single-centre, randomised, repeated-dose (once daily for six consecutive days), open-label, two-way crossover study, with a washout period of at least 9 days between treatments. Plasma samples were collected up to 12 h post-dosing for the determination of omeprazole by HPLC with photodiode array detector (DAD).

The evaluation of bioequivalence was based on the following pharmacokinetic parameters that were calculated by standard non-compartmental methods: area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUCt) and that extrapolated to infinity (AUC) and the maximum observed concentration (Cmax). The 90% confidence interval around the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 0.92-1.04 for Cmax, 0.88-1.05 for AUCt, and 0.88-1.05 for AUC, i.e., within the predefined acceptable range for the conclusion of bioequivalence. The study indicated that the test and reference formulations containing 20 mg of omeprazole are bioequivalent in terms of both the rate and extent of bioavailability.

 
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