Art

J-GLOBAL ID：201802219160036540   Reference number：18A0930990

Evaluation of Bioequivalence Between the New Procaterol Hydrochloride Hydrate Dry Powder Inhaler and the Approved Dry Powder Inhaler in Patients With Asthma in a Randomized, Double-Blind, Double-Dummy, Crossover Comparison Study: A Phase 3 Study

無作為化,二重盲検,二重ダミー,交差比較試験における喘息患者における新しい塩酸プロカテロール水和物乾燥粉末吸入器と承認乾燥粉末吸入器の間の生物学的同等性の評価:第3相試験【JST・京大機械翻訳】

Author (10)： Shirai Ryo (Bungoono City Hospital, Oita, Japan) ,  Shirai Ryo (Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine, Oita, Japan) ,  Suzaki Yuki (General Clinical Research Center, Oita University Hospital, Oita, Japan) ,  Sato Kyoko (General Clinical Research Center, Oita University Hospital, Oita, Japan) ,  Takeuchi Yuko (General Clinical Research Center, Oita University Hospital, Oita, Japan) ,  Tokimatsu Issei (Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine, Oita, Japan) ,  Tokimatsu Issei (Department of Infection Control and Prevention, Kobe University Hospital, Kobe, Japan) ,  Koga Nobuyuki (Department of Medical Affairs, Otsuka Pharmaceutical Co, Ltd, Tokushima, Japan) ,  Kadota Junichi (Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine, Oita, Japan) ,  Ohashi Kyoichi (General Clinical Research Center, Oita University Hospital, Oita, Japan)
Material： Clinical Pharmacology in Drug Development
Volume： 7  Issue： 4  Page： 392-399  Publication year： 2018 
JST Material Number： W2780A  ISSN： 2160-7648  Document type： Article
Article type： 原著論文  Country of issue： United States (USA)  Language： ENGLISH (EN)

Abstract/Point： Procaterol hydrochloride hydra...

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Thesaurus term： bronchial asthma ,  vital capacity ,  chronic obstructive pulmonary disease ,  *phase 3 study ,  Safety ,  adrenergic drug ,  bronchodilator action ,  *equivalency ,  administration (biology) ,  *bioequivalence ,  *double blind test ,  *patient ,  nitrogen heterocyclic compound ,  phenolic compound ,  polynuclear aromatic compound ,  aminoalcohol ,  diol ,  secondary amine ,  secondary alcohol ,  lactam
Semi thesaurus term： *乾燥粉末吸入器 , 【Automatic Indexing@JST】

Author keywords (5)： pharmacodynamic equivalence ,  dry powder inhaler ,  procaterol ,  asthma ,  device

JST classification (2)： Drug therapy(=pharmacotherapy)for respiratory system diseases  (GI05020J) ,  Clinical application of drugs acting on respiration and respiratory system  (GW08020U)

Substance index (2)： Procaterol ,  Procaterol hydrochloride

Terms in the title (13)： 二重盲検 ,  ダミー ,  交差 ,  比較試験 ,  喘息 ,  患者 ,  塩酸プロカテロール ,  水和物 ,  乾燥粉末吸入器 ,  承認 ,  生物学的同等性 ,  評価 ,  第3相試験