A Randomized, Double-Blind, Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers (Vifor SA and Biogen Idec OSD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 19.0 to 30.0 kg/m2, inclusive
- •Subjects of reproductive potential must agree to practice effective contraception from at least 14 days prior to the first dose of study drug through at least 30 days after their last dose of study drug.
排除标准
- •History of any clinically significant cardiac, endocrine, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- •Treatment with another investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Reference, Test, Reference (RTR)
Doses will be separated by a washout period
干预措施: dimethyl fumarate - Reference form (Drug)
Reference, Test, Reference (RTR)
Doses will be separated by a washout period
干预措施: dimethyl fumarate - Test form (Drug)
Test, Reference, Reference (TRR)
Doses will be separated by a washout period
干预措施: dimethyl fumarate - Reference form (Drug)
Test, Reference, Reference (TRR)
Doses will be separated by a washout period
干预措施: dimethyl fumarate - Test form (Drug)
结局指标
主要结局
Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012
时间窗: Up to 48 hours following each dose administration
Maximum observed concentration (Cmax) of BG00012
时间窗: Up to 48 hours following each dose administration
次要结局
- The number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Day 13)
- Apparent clearance (CL/F)(Up to 48 hours following each dose administration)
- Lag time (tlag)(Up to 48 hours following each dose administration)
- Half-life (t1/2)(Up to 48 hours following each dose administration)
- Area under the plasma concentration curve from time of dosing to 48 hours(Up to 48 hours following each dose administration)
- Intra-subject coefficient of variation (CV%) of the reference product for area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax)(Up to 48 hours following each dose administration)
- Time to peak plasma concentration (Tmax)(Up to 48 hours following each dose administration)