NCT01420458已完成1 期
A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.
适应症
相关药物
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 plasma concentration curve as a measure of PK.
研究概览
简要总结
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
详细描述
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •Must give written and informed consent and any authorizations required by local law.
- •Males and females 18 - 55 years old inclusive at time of consent.
- •Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive
排除标准
- •History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- •Known history of or positive test result for Human Immunodeficiency Virus (HIV)
- •History of severe allergic or anaphylactic reactions.
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
- •Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
- •Current enrollment in any other drug, biologic, or device study.
结局指标
主要结局
Area under the plasma concentration curve as a measure of PK.
时间窗: Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs
次要结局
- The number of AEs in participants as a measure of safety and tolerability.(Participants will be followed during the time of study - an estimated four days)
研究者
研究点 (1)
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