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

NCT ID: NCT01632449

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

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.

Conditions

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Healthy Volunteers

Keywords

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bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Test product

Group Type EXPERIMENTAL

Test product

Intervention Type DRUG

Dimethyl Fumarate (BG00012)

Reference product

Intervention Type DRUG

Dimethyl Fumarate (BG00012)

2

Reference product

Group Type EXPERIMENTAL

Test product

Intervention Type DRUG

Dimethyl Fumarate (BG00012)

Reference product

Intervention Type DRUG

Dimethyl Fumarate (BG00012)

Interventions

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Test product

Dimethyl Fumarate (BG00012)

Intervention Type DRUG

Reference product

Dimethyl Fumarate (BG00012)

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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109HV109

Identifier Type: -

Identifier Source: org_study_id