書誌事項
- タイトル別名
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- <b>Bioequivalence Study of Fentanyl Tape for 1 Day without Use of Antinarcotic in Healthy Male Japanese Subjects </b>
説明
<p>FENTANYL Tape for 1 Day ⌈MEIJI⌋ is a generic drug of OneDuro® Patch (Janssen Pharmaceutical K.K.) under development by Meiji Seika Pharma Co., Ltd. and Yutoku Pharmaceutical Ind. Co., Ltd. The generic drug contains the same active ingredient fentanyl at the same dose in the same dosage form (transdermal absorption) as the original drug. In this study, 32 healthy male Japanese adults were recruited as subjects. Each subject applied a FENTANYL Tape for 1 Day 0.84 mg ⌈MEIJI⌋ and a OneDuro® Patch 0.84 mg once in a crossover manner, without concomitant use of antinarcotic. Bioequivalence of these drugs was investigated by analyzing pharmacokinetic parameters (Cmax and AUC0→t) as primary endpoints calculated from serum fentanyl concentration profiles in all 32 subjects. The results confirmed bioequivalence of the two products. Secondary endpoints including pharmacokinetic parameters such as AUC0→∞, MRTt and kel also supported bioequivalence of the two products. When a FENTANYL Tape for 1 Day 0.84 mg ⌈MEIJI⌋ or a OneDuro® Patch 0.84 mg was applied once for 24 hours without concomitant use of antinarcotic, there were no adverse events such as cutaneous reactions at the application site.</p>
収録刊行物
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- 臨床薬理
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臨床薬理 47 (4), 137-142, 2016
一般社団法人 日本臨床薬理学会
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詳細情報 詳細情報について
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- CRID
- 1390001205367406720
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- NII論文ID
- 130005169004
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- ISSN
- 18828272
- 03881601
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
- Crossref
- CiNii Articles
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- 抄録ライセンスフラグ
- 使用不可
