Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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.
