Relative bioavailability of two enteric-coated formulations of omeprazole following repeated doses in healthy volunteers

• Type: Article in International Scientific Journal
• Date: 2001

Authors

Vaz Da Silva, M (Author) FMUP; Hainzl, D (Author) Other; Almeida, L (Author) Other; Dolgner, A (Author) Other; Silveira, P (Author) Other; Maia, J (Author) Other; soares-da-silva, p (Author) FMUP

Journal

Title: Clinical Drug Investigation

Vol. 21

Pages: 203-210

ISSN: 1173-2563

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 1 Citation

Scopus - 2 Citations

Other information

Authenticus ID: P-000-WWZ

DOI: 10.2165/00044011-200121030-00006

Abstract (EN): Objective: This study aimed to investigate the relative bioavailability and bioequivalence of two omeprazole enteric-coated formulations following repeated doses (steady state) in healthy male and female adult volunteers. Design and Study Participants: The study formulation (Ompranyt (R) 20mg capsules, Bial-Industrial Farmaceutica SA, Spain) was compared with an omeprazole reference formulation (Mopral (R) 20mg capsules, Laboratorio Astra, Spain). 24 participants were randomised using a two-way, crossover design to receive either one capsule/day of Ompranyt (R) or one capsule/day of Mopral (R) during two sequential periods of five consecutive days each. The participants were administered the drugs in the fasting state. Omeprazole concentrations in plasma samples were quantified by a validated method using a reversed-phase high performance liquid chromatography with UV detection (HPLC-UV). The validation method is described. Setting: The study was conducted at the Human Pharmacology Unit, Department of Research & Development, Laboratories Bial (S. Mamede do Coronado, Portugal). Results: The arithmetic mean +/- SD values of the area under the plasma concentration Versus time curve from time zero to infinity (AUC(0-infinity),) were 1474 +/- 1417 mug/L .h for Ompranyt (R) and 1490 +/- 1276 mug/L .h for Mopral (R). The geometric means ratio (Ompranyt (R) /Mopral (R)) was 0.99, with 90% confidence intervals (CI) of 0.97-1.03. The estimated maximum plasma concentration (C-max) was 630.1 +/- 516.7 mug/L for Ompranyt (R) and 736.7 +/- 443.3 mug/L for Mopral (R), with a geometric means ratio (Ompranyt (R) /Mopral (R)) of 0.96 (90% CI: 0.94-0.99). Bioequivalence of these two formulations was accepted based on the two one-sided ANOVA for AUC(0-infinity) as well as for Cmax. In both cases, the 90% CI lies within the acceptance range of 0.80-1.25. Conclusion: Bioequivalence of Ompranyt (R) and Mopral (R) was demonstrated after repeated drug administration in fasting conditions, and both products were similarly well tolerated. Therefore, both formulations are expected to be equivalent in a clinical setting.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 8