{"created":"2023-05-26T01:05:05.593785+00:00","id":2006265,"links":{},"metadata":{"_buckets":{"deposit":"6dbcc865-f6c1-48e5-a076-93f922840b37"},"_deposit":{"created_by":17,"id":"2006265","owners":[17],"pid":{"revision_id":0,"type":"depid","value":"2006265"},"status":"published"},"_oai":{"id":"oai:nagoya.repo.nii.ac.jp:02006265","sets":["499:508:509:1685060434835"]},"author_link":[],"control_number":"2006265","item_1615768549627":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_9_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2023-05","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"2","bibliographicPageEnd":"274","bibliographicPageStart":"265","bibliographicVolumeNumber":"85","bibliographic_titles":[{"bibliographic_title":"Nagoya Journal of Medical Science","bibliographic_titleLang":"en"}]}]},"item_9_description_4":{"attribute_name":"内容記述","attribute_value_mlt":[{"subitem_description":"Bioequivalence test should be carried out for copy medicine, including dihydroartemisinin-piperaquine (DHP), which is used to treat critical diseases requiring medication. To predict the bioequivalence of film coated DHP generic tablets compared to the reference, a randomized controlled trial, single blind, single dose cross over design, two sequences, 2 periods, and wash-out period 7 days was conducted on 8 healthy adults. Blood samples were taken at certain times; plasma levels of dihydroartemisinin (DHA) were determined and analyzed for pharmacokinetics profile using UPLC MS MS system. The mean ±SD of AUC0-24, Cmax, Tmax, and T½ of the test drug (T) in the following order were 220.07 ± 64.48 ng.mL-1.hour; 119.00 ± 37.66 ng.mL-1.hour; 1.16 ± 0.30 hour; and 1.06 ± 0.31 hour. The mean ±SD of AUC0-24, Cmax, Tmax, and T½ of the reference drug (R) were 301.91 ± 161.30 ng.mL-1.hour; 203.60 ± 91.04 ng.mL-1.hour; 0.94 ± 0.35 hour; and 0.80 ± 0.21 hour. Based on statistical analysis, the geometrics mean ratio (T/R) for the Cmax and AUC0-t were 0.6083 with 90% CI (0.4853–0.7624) and 0.7769 with 90% CI (0.6493–0.9295) respectively. Kinetic profiles between the two products were the same, however the test drug is relatively inferior compared to the reference drug.","subitem_description_language":"en","subitem_description_type":"Abstract"},{"subitem_description":"This is an Open Access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view the details of this license, please visit (http://creativecommons.org/licenses/by-nc-nd/4.0/).","subitem_description_language":"en","subitem_description_type":"Other"}]},"item_9_identifier_registration":{"attribute_name":"ID登録","attribute_value_mlt":[{"subitem_identifier_reg_text":"10.18999/nagjms.85.2.265","subitem_identifier_reg_type":"JaLC"}]},"item_9_publisher_32":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"Nagoya University Graduate School of Medicine, School of Medicine","subitem_publisher_language":"en"}]},"item_9_relation_43":{"attribute_name":"関連情報","attribute_value_mlt":[{"subitem_relation_type":"isVersionOf","subitem_relation_type_id":{"subitem_relation_type_id_text":"https://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/852.html","subitem_relation_type_select":"URI"}}]},"item_9_rights_12":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International","subitem_rights_language":"en","subitem_rights_resource":"http://creativecommons.org/licenses/by-nc-nd/4.0/"}]},"item_9_source_id_7":{"attribute_name":"収録物識別子","attribute_value_mlt":[{"subitem_source_identifier":"0027-7622","subitem_source_identifier_type":"PISSN"},{"subitem_source_identifier":"2186-3326","subitem_source_identifier_type":"EISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_abf2"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Isnawati, Ani","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Gitawati, Retno","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Alegantina, Sukmayati","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Setyorini, Herni Asih","creatorNameLang":"en"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_access","date":[{"dateType":"Available","dateValue":"2023-05-26"}],"displaytype":"detail","filename":"06_Isnawati.pdf","filesize":[{"value":"987 KB"}],"format":"application/pdf","licensetype":"license_5","mimetype":"application/pdf","url":{"objectType":"fulltext","url":"https://nagoya.repo.nii.ac.jp/record/2006265/files/06_Isnawati.pdf"},"version_id":"e9392481-76a9-4f1f-bd9b-93866a904595"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"dihydroartemisinin-piperaquine (DHP)","subitem_subject_scheme":"Other"},{"subitem_subject":"dihydroartemisinin (DHA)","subitem_subject_scheme":"Other"},{"subitem_subject":"bioequivalence","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"departmental bulletin paper","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers","subitem_title_language":"en"}]},"item_type_id":"40001","owner":"17","path":["1685060434835"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2023-05-26"},"publish_date":"2023-05-26","publish_status":"0","recid":"2006265","relation_version_is_last":true,"title":["Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers"],"weko_creator_id":"17","weko_shared_id":-1},"updated":"2023-05-26T01:34:34.881911+00:00"}