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项与 Banner Pharmacaps BV 相关的药物

Chlorotrianisene

氯烯雌醚

靶点

ER

作用机制

ERs激动剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期1984-01-01

100 项与 Banner Pharmacaps BV 相关的临床结果

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0 项与 Banner Pharmacaps BV 相关的专利（医药）

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2

项与 Banner Pharmacaps BV 相关的文献（医药）

2008-07-01·Current Medical Research and Opinion4区 · 医学

Bioequivalence studies of a new valproic acid delayed-release capsule and divalproex sodium delayed-release tablet

4区 · 医学

Article

作者: Toops, Dana S. ; Fang, Qi ; Garikipati, Vandana

OBJECTIVEThe study examined relative bioavailability of a novel valproic acid (VPA) delayed-release (DR) soft gelatin capsule formulation to divalproex sodium DR tablet under fasting conditions and the effect of food on the bioavailability of the VPA DR soft gelatin capsule.METHODThis open-label, randomized three-way crossover study enrolled 36 healthy non-smoking adult volunteers. Treatments included a single 500 mg divalproex sodium DR tablet, fasting; a single 500 mg VPA DR soft gelatin capsule, fasting; and, a single 500 mg VPA DR soft gelatin capsule 500 mg, non-fasting. Analysis of variance was performed on the pharmacokinetic parameters. The ratio of geometric means and corresponding 90% confidence intervals (CI) were calculated on ln-transformed data for the area under the serum concentration-time curve (mug-hr/mL) from time zero to the time of the last quantifiable concentration (t) (AUC(0-t)), AUC(0-infinity) and maximum plasma concentration (C(max)). Bioequivalence was shown when 90% CIs were within the 80-125% range.RESULTSAll subjects completed the study. The 90% CIs of VPA DR soft gelatin capsules compared to divalproex sodium DR tablets were within the 80-125% limits for AUC(0-t), AUC(0-infinity), and C(max). The time of maximum or peak concentration (T(max)) of VPA DR soft gelatin capsules was 2.3 hours versus 3.7 hours with divalproex sodium DR tablets. AUC(0-t) and AUC(0-infinity) of VPA soft gelatin capsules were not affected in the non-fasting condition, but T(max) occurred at 6.1 hours compared to 2.3 hours fasting. Eight subjects experienced a total of 10 adverse events; none were serious.CONCLUSIONThe VPA DR soft gelatin capsule formulation was shown to be bioequivalent to divalproex sodium DR tablet and no serious adverse events occurred. Because this was not a multiple-dose study, however, direct comparisons in chronic dosing were not possible. Administration with food affected rate but not extent of absorption of the VPA DR soft gelatin capsules, but comparisons with the reference product were not conducted under non-fasting conditions.

American Environmental Laboratory

Bioconversion of organic wastes to ethanol using immobilized thermophilic bacteria

作者: Padmanabhan, Anand P. ; Kumar, Jothi V. ; Shahbazi, Abolghasem

A fluidized bed reactor was designed and used to convert liquid organic wastes to ethanol using Clostridium thermocellum and Thermoanaerobacter ethanolicus.

100 项与 Banner Pharmacaps BV 相关的药物交易

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100 项与 Banner Pharmacaps BV 相关的转化医学

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