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Accession number;04A0542890
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| Title;Bioequivalence Studies of Omeprazole Enteric-Coated New Tablet Formulation |
| Author;
KITAMORI NOBUYUKI
(Sawai Pharm. Co., Ltd.)
HIZAKI MASAYA
(Sawai Pharm. Co., Ltd.)
SASAKI YOSHINORI
(Sawai Pharm. Co., Ltd.)
YAMASAKI SHINJI
(Sawai Pharm. Co., Ltd.)
FUKUMORI YOSHINOBU
(Kobe Gakuin Univ., Fac. Pharmaceutical Sciences, JPN)
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Journal Title;Japanese Pharmacology & Therapeutics
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Journal Code:Z0947A
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ISSN:0386-3603
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VOL.32;NO.6;PAGE.379-384(2004)
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| Figure&Table&Reference;FIG.5, TBL.3, REF.6 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A new tablet formulation of acid pump inhibitor omeprazole has been developed. Bioequivalence between an omeprazole reference formulation (Omepral Tablets 20mg, Astra-Zeneca) and the formulation developed was investigated under fasting conditions in a randomized crossover design. Plasma omeprazole concentrations were measured by HPLC technique. Both formulations were found to be equivalent using the criteria of "Guidelines for bioequivalence testing of generic drugs" in terms of AUG and Tmax. However, the mean plasma omeprazole concentration profiles for both formulations were not superimposable. This may be caused by that the gastric emptying times of enteric-coated tablets are different among persons and periods. Our results obtained will be discussed from a viewpoint of gastric emptying time. (author abst.) |
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