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DataCite Commons2025-07-07 更新2026-05-07 收录
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https://search.vivli.org/doiLanding/dataPackages/PR00003194.0
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The primary objective of this study is to establish the bioequivalence of the test product (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers. The secondary objectives of this study are to determine the safety and tolerability of the test product compared to the reference product, to estimate PK parameters of the test product and the reference product, and to estimate the intra-subject coefficient of variation (CV%) of the referenced product for both area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax).
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Vivli
创建时间:
2025-07-07
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