| Item type |
itemtype_ver1(1) |
| 公開日 |
2023-05-26 |
| タイトル |
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|
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
Gitawati, Retno
Alegantina, Sukmayati
Setyorini, Herni Asih
|
| アクセス権 |
|
|
アクセス権 |
open access |
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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 |
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|
主題Scheme |
Other |
|
主題 |
dihydroartemisinin (DHA) |
| キーワード |
|
|
主題Scheme |
Other |
|
主題 |
bioequivalence |
| 内容記述 |
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|
内容記述タイプ |
Abstract |
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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 |
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|
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 |
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|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
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 |
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|
ID登録 |
10.18999/nagjms.85.2.265 |
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ID登録タイプ |
JaLC |
| 関連情報 |
|
|
関連タイプ |
isVersionOf |
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|
識別子タイプ |
URI |
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|
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 |
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|
収録物識別子タイプ |
PISSN |
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収録物識別子 |
0027-7622 |
| 収録物識別子 |
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収録物識別子タイプ |
EISSN |
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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
|
06_Isnawati.pdf (987 KB)
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