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Pharmacokinetics,Tolerability,and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects

Pharmacokinetics,Tolerability,and Bioequivalence of Two Form...

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首届东方药理论坛暨2018年全国心脑血管药理学术会议、上海市药理学会第十九届学术年会

作者： YunLiu Brian Tomlinson Jiyuan Guo mahnaz asghamejad Lars Bauer Erwin Surmann Xiaojuan Guo Jan-Peer Elshoff Shanghai Xuhui Central Hospital Prince of Wales Hospital UCB Pharma

Purpose:The pharmacokinetics(PK) of rotigotine transdermal patch are well characterized in Caucasian patients with Parkinson's disease(PD) but not in Chinese *** report the PK,safety,and tolerability of rotigotine transdermal patch(2 mg/24 hours and 4 mg/24 hours cold-chain PR2.1.1 formulation) in healthy Chinese subjects(SP0913;NCT01675024).A second separate study(PD0011;NCT02070796)evaluated the relative bioavailability of the cold-chain(PR2.1.1) and room temperature stable(PR2.2.1) formulations of rotigotine in healthy Chinese ***:In Treatment Period 1 of study SP0913,subjects received a single application of rotigotine 2 mg/24 hours on day 1 followed by a washout period(days2-6);Treatment Period 2(days 6-14) involved multiple doses of rotigotine 2 mg/24 hours(days 7-9) followed by multiple doses of rotigotine 4 mg/24 hours(days 10-12),with patches applied for 24 hours *** study PD0011,subjects received a single dose(2 mg/24 hours) of each rotigotine formulation(PR2.2.1 and PR2.1.1) for 24 hours each in a crossover *** samples were collected at scheduled time points to determine plasma concentrations of *** and tolerability were evaluated by adverse events ***:Twenty-four healthy(12 male,12 female) Chinese subjects were enrolled and completed *** mean plasma concentrations of unconjugated and total rotigotine increased to a plateau beginning at～8 hours(multiple dose) to 16 hours(single dose) post-dose;no characteristic Tmax was observed for unconjugated and total *** respective geometric mean Cmax,Cmax,ss,AUC0-tz,AUC0-24,ss values for unconjugated and total rotigotine were similar when rotigotine2 mg/24 hours was applied as a single dose and as a multiple-dose *** the multiple-dose period,geometric mean Cmax,ss and AUC0-24,ss of both unconjugated and total rotigotine were-2-fold higher for rotigotine 4 mg/24 hours than for rotigotine 2 mg/24 ***-seven of 50 male C

关键词： bioequivalence Chinese dopamine agonist pharmacokinetics rotigotine tolerabiity transdermal delivery

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