A bioequivalence study of two different crystalline forms of malotilate: A and B.
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概要
- 論文の詳細を見る
Malotilate (diisopropyl-1, 3-dithio1-2-ylidenemalonate) exists in two polymorphic forms, designated A and B. The transformation from A to B easily occurs at relatively low temperatures. Since different crystalline forms of a drug may influence its absorption and hence its therapeutic efficacy, two crystalline forms of malotilate (A and B) were assessed in 20 healthy male subjects using a two-way cross-over design. The concentration-time curve was shifted slightly to the right in the group that received the B form; however, there were no significant differences in the AUC, C<SUB>max</SUB>, and t<SUB>max</SUB> between the two groups. Statistical evaluation of the data involved an analysis of variance for a cross-over design (ANOVA). This revealed significant differences for "Time Periods" and "Between Subjects, " but not for "Group or Sequence" or "Drugs." With 95% confidence, the confidence intervals of each parameter satisfied the criteria for AUC but not for C<SUB>max</SUB> and t<SUB>max</SUB>. From the data obtained and taking into consideration their clinical use, we conclude that both the A and B forms of malotilate are bioequivalent.
- 一般社団法人 日本臨床薬理学会の論文
著者
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Oguchi Katsuji
Department Of Pharmacology School Of Medicine Showa University
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Sakamoto Koji
Department Of Pharmacology School Of Medicine Showa University
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Kobayashi Shinichi
Department Of Biomedical Engineering Graduate School Of Medicine University Of Tokyo
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Uchida Eiji
Department Of Cardiology Seirei Yokohama General Hospital
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Yasuhara Hajime
Department Of Neonatal Intensive Care Unit Nara Prefectural Hospital
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UCHIDA Eiji
Department of Pharmacology, School of Medicine, Showa University
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