Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.

Key facts

Study ID

NCT01632449

Run by

Biogen

People needed

80

Starts

2012-07-01

Expected to finish

2012-09-01

Last updated by the study team

2013-05-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify 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 qualify if…

• History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
• 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.

Where it is running

• Research Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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