{"_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": ["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", "download_preview_message": "", "file_order": 0, "filename": "06_Isnawati.pdf", "filesize": [{"value": "987 KB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensetype": "license_5", "mimetype": "application/pdf", "size": 987000.0, "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"], "permalink_uri": "https://doi.org/10.18999/nagjms.85.2.265", "pubdate": {"attribute_name": "PubDate", "attribute_value": "2023-05-26"}, "publish_date": "2023-05-26", "publish_status": "0", "recid": "2006265", "relation": {}, "relation_version_is_last": true, "title": ["Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers"], "weko_shared_id": -1}
Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers
https://doi.org/10.18999/nagjms.85.2.265
https://doi.org/10.18999/nagjms.85.2.265