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

Biogen

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Reference product

Drug: Test product

Study type

Interventional

Funder types

Industry

Identifiers

NCT01632449

109HV109

Details and patient eligibility

About

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.

Full description

This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.

Enrollment

80 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.