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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Test product
* Drug: Reference product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Test product | Drug: Test product<br>* Dimethyl Fumarate (BG00012)<br>Drug: Reference product<br>* Dimethyl Fumarate (BG00012)<br>|
| Experimental: 2<br>Reference product | Drug: Test product<br>* Dimethyl Fumarate (BG00012)<br>Drug: Reference product<br>* Dimethyl Fumarate (BG00012)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK - Area under the plasma concentration curve. |  | Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours | 
| Peak plasma concentration as a measure of PK. |  | Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of AEs in participants as a measure of safety and tolerability. |  | Participants will be followed during the study, 4 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence