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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.85.2.2654ad5b846-f984-440d-b512-1912f5ff5999
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
06_Isnawati.pdf (987 KB)
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| Item type | itemtype_ver1(1) | |||||||||||||
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| 公開日 | 2023-05-26 | |||||||||||||
| タイトル | ||||||||||||||
| タイトル | Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers | |||||||||||||
| 言語 | en | |||||||||||||
| 著者 |
Isnawati, Ani
× Isnawati, Ani
× Gitawati, Retno
× Alegantina, Sukmayati
× Setyorini, Herni Asih
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| アクセス権 | ||||||||||||||
| アクセス権 | open access | |||||||||||||
| アクセス権URI | http://purl.org/coar/access_right/c_abf2 | |||||||||||||
| 権利 | ||||||||||||||
| 言語 | en | |||||||||||||
| 権利情報Resource | http://creativecommons.org/licenses/by-nc-nd/4.0/ | |||||||||||||
| 権利情報 | Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International | |||||||||||||
| キーワード | ||||||||||||||
| 主題Scheme | Other | |||||||||||||
| 主題 | dihydroartemisinin-piperaquine (DHP) | |||||||||||||
| キーワード | ||||||||||||||
| 主題Scheme | Other | |||||||||||||
| 主題 | dihydroartemisinin (DHA) | |||||||||||||
| キーワード | ||||||||||||||
| 主題Scheme | Other | |||||||||||||
| 主題 | bioequivalence | |||||||||||||
| 内容記述 | ||||||||||||||
| 内容記述タイプ | Abstract | |||||||||||||
| 内容記述 | 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. | |||||||||||||
| 言語 | en | |||||||||||||
| 内容記述 | ||||||||||||||
| 内容記述タイプ | Other | |||||||||||||
| 内容記述 | 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/). | |||||||||||||
| 言語 | en | |||||||||||||
| 出版者 | ||||||||||||||
| 出版者 | Nagoya University Graduate School of Medicine, School of Medicine | |||||||||||||
| 言語 | en | |||||||||||||
| 言語 | ||||||||||||||
| 言語 | eng | |||||||||||||
| 資源タイプ | ||||||||||||||
| 資源タイプresource | http://purl.org/coar/resource_type/c_6501 | |||||||||||||
| タイプ | departmental bulletin paper | |||||||||||||
| 出版タイプ | ||||||||||||||
| 出版タイプ | VoR | |||||||||||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||||||||||
| ID登録 | ||||||||||||||
| ID登録 | 10.18999/nagjms.85.2.265 | |||||||||||||
| ID登録タイプ | JaLC | |||||||||||||
| 関連情報 | ||||||||||||||
| 関連タイプ | isVersionOf | |||||||||||||
| 識別子タイプ | URI | |||||||||||||
| 関連識別子 | https://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/852.html | |||||||||||||
| 収録物識別子 | ||||||||||||||
| 収録物識別子タイプ | PISSN | |||||||||||||
| 収録物識別子 | 0027-7622 | |||||||||||||
| 収録物識別子 | ||||||||||||||
| 収録物識別子タイプ | EISSN | |||||||||||||
| 収録物識別子 | 2186-3326 | |||||||||||||
| 書誌情報 |
en : Nagoya Journal of Medical Science 巻 85, 号 2, p. 265-274, 発行日 2023-05 |
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Cite as
Isnawati, Ani, Gitawati, Retno, Alegantina, Sukmayati, Setyorini, Herni Asih, 2023, Pilot study: bioequivalence of dihydroartemisinin in dihydroartemisinin-piperaquine tablet generic formulation in healthy Indonesian volunteers: Nagoya University Graduate School of Medicine, School of Medicine, 265–274 p.
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