A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers

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

2014-06-30

Study Completion Date

2014-07-31

Brief Summary

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The primary objective of this study is to establish the bioequivalence of the test product (BG00012 \[dimethyl fumarate\] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.

The secondary objectives of this study are to determine the safety and tolerability of the test product compared to the reference product, to estimate PK parameters of the test product and the reference product, and to estimate the intra-subject coefficient of variation (CV%) of the referenced product for both area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reference, Test, Reference (RTR)

Doses will be separated by a washout period

Group Type ACTIVE_COMPARATOR

dimethyl fumarate - Reference form

Intervention Type DRUG

single dose 240 mg

dimethyl fumarate - Test form

Intervention Type DRUG

single dose 240 mg

Test, Reference, Reference (TRR)

Doses will be separated by a washout period

Group Type ACTIVE_COMPARATOR

dimethyl fumarate - Reference form

Intervention Type DRUG

single dose 240 mg

dimethyl fumarate - Test form

Intervention Type DRUG

single dose 240 mg

Interventions

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dimethyl fumarate - Reference form

single dose 240 mg

Intervention Type DRUG

dimethyl fumarate - Test form

single dose 240 mg

Intervention Type DRUG

Other Intervention Names

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BG00012 Tecfidera® BG00012

Eligibility Criteria

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Inclusion Criteria

* BMI of 19.0 to 30.0 kg/m2, inclusive
* Subjects of reproductive potential must agree to practice effective contraception from at least 14 days prior to the first dose of study drug through at least 30 days after their last dose of study drug.

Exclusion Criteria

* History of any clinically significant cardiac, endocrine, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
* Treatment with another investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes