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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01632449

Enrollment

Registered

2012-07-03

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

bioequivalence

Brief summary

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

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.

Interventions

DRUGTest product

Dimethyl Fumarate (BG00012)

DRUGReference product

Dimethyl Fumarate (BG00012)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026